notes/DC Dutta Obstetrics 10th Edition_16.txt

CONTRACEPTIVE EFFECTIVENESS: The failure rate of any contraceptive is calculated in terms of pregnancy rate per Hundred Women Years (HWY) of use. It is calculated according to the following formula (Pearl index):
Pregnancy failure rate/HWY
_    Number of accidental pregnancies x 1,200* Number of patients observed x months of use
• 1,200 = number of months in 100 years
Example: If 100 couples have used a method for a period of  2  years  and  have resulted  in  20  pregnancies,  the
1200
24
20
X
100
.
pregnancy rate 1s calculated to be: ---- == 10 X
When the pregnancy rate is below 10, the effectiveness of the particular method is considered to be high. If it is more than 20, it is said to be low. The following are the effectiveness of the commonly used contraceptive methods.

METHODS OF CONTRACEPTIONS
The various methods of contraception are schematically depicted here (Flowchart 36.1 and Fig. 36.1).
Contraception is a preventive issue. Nearly 55% of all Indian women are using a contraceptive method.  There are several noncontraceptive benefits of contraceptives. The preferred method of contraception for a women may change over for phases of life. "Tiers of effectiveness" of contraceptive methods are based on pregnancy rates with their perfect use and typical use (Table 36.1).
The Medical Eligibility Criteria (MEC) provides the guidance for safe use of contraceptives for any woman with medical comorbidities (Table 36.2).

Flowchart 36.1: Methods of Contraception.
Methods of Contraception

Implants (2%)
Fig.   36.1:   Methods   of   Contraception   used   by   women   of reproductive age (15-49 years); Worldwide.
Source: United Nations-data booklet of World Contraceptive Use 2019.
I TEMPORARY METHODS
Temporary methods are commonly used to postpone or to space births.  However, these methods are also frequently being used by the couples even though they desire no more children.

INTRAUTERINE CONTRACEPTIVE DEVICES (IUCDS)

The Intrauterine Contraceptive Devices (IUCDs) have been used worldwide. It is a safe, effective and reversible method of contraception.  The efficacy  of IUCDs  are comparable with surgical sterilization.
There has been a significant improvement in its design and content. The idea is to obtain maximum eficacy without increasing the adverse effects. The device is classified as open, when it has got no circumscribed aperture of more than 5 mm so that a loop of intestine or omentum cannot enter and become strangulated if, accidentally, the device perforates through the uterus into the peritoneal cavity. Cu-T,  Multiload 375 are examples  of open  devices.  The device may be medicated (bioactive) by incorporating a metal copper, in devices like Cu-T 380A, Multiload-375 (Figs. 36.2A to C) or it may be hormonally active (LNG-IUS).
Types of IUCDs:  The copper T-380A is commonly used. The amount of copper that comes out of the device on daily basis amounts to less than that ingested in the normal diet.
Hormone-containing IUDs either releasing progester­ one (progestasert) or levonorgestrel (LNG-IUS) has also been introduced.  Nowadays,  the following medicated IUDs are in use:

+   Cu-T 380A.	+   LNG-IUS.

•  Barrier methods (p. 518).
•  Natural contraception.
•  Intrauterine contraceptive. devices (IUCDs).
•  Steroidal contraception.



Female • Tubal
occlusion.



Male
• Vasectomy.

•    Multiload 375.	•   Skyla.
Description of the devices (Figs. 36.2A to CJ
Cu-T 380A: It is a medicated device containing copper.
It carries 380 mm2  of copper in total. The vertical stem
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(FirstTier} Most Effective IUCD: Intrauterine devices
Levonorgestrel system	0.1	0.1 T 380A copper	0.6	0.8 Levonorgestrel implants	0.05	0.05 Sterilization:
Female	0.5	0.5 Male	0.1	0.15
(Second Tier} Very Effective
Combination pill	0.3	9 Vaginal ring	0.3	9 Patch	0.3	9 DMPA	0.2	6 Progestin-only pill	0.3	9 (Third Tier} Effective Condom
Male                                                                 2                      18 Female                                                             5                      21
Diaphragm with                                             6                      12 spermicides                                                                            12
Fertility-awareness
Standard days	5 Two days	4 Ovulation	3 Symptothermal
0.4
(FourthTier} Least Effective
Spermicides	18	28 Sponge
Parous women	20	24



The stem of the device is made of polyethylene frame. These two threads are used for detection and removal of the device. In spite of copper being radiopaque, additional barium sulfate is incorporated in the device. The device is replaced every 10 years. However, this Cu-T 380A device has been used to prevent pregnancy for 20 years. Women desiring for continued contraception, the existing device can be removed at the end of the schedule time and a new device can be inserted during the same time. Apart from the use of Cu-T as a contraceptive (both LARC and Emergence Contraceptive), it is used following synecolysis to  prevent  recurrent  adhesion  formation.  Devices containing less than 300 mm2  of copper have higher failure rate.
Multiload Cu-375: The device is available in a sterilized sealed packet with an applicator. There is no introducer and no plunger. It has 375 mm2 surface area of copper wire wound around its vertical stem. Replacement is every 5 years (Fig. 36.2A).
Levonorgestrel-intrauterine  system  (LNG-IUS) (Fig. 36.2B): This is a T -shaped device, with polydimethyl­ siloxane membrane  around  the  stem  which  acts  as  a steroid reservoir. Total amount of levonorgestrel is 52 mg and is released at the rate 20 µg/ day. This device is to be replaced every 7 years though approved for 5 years. Its eficacy is comparable to sterilization operation. It has many noncontraceptive benefits also.
■    LNG-IUD 19.5 mg (Kyleena) initially releases 17.5 µg LNG daily. It is effective for 5 years.
■    LNG-IUD 13.5 mg (Skyla) initially releases 14 µg LNG daily for 3 years (Fig. 36.2D).
■    The 19.5 mg and 13.5 mg LNG-IUD are smaller in size (28 mm x 30 mm). These two are approved for small size uterus. These are more suitable for nulliparous women.



Nulliparous women	9	12 No Category
Withdrawal                                                 4                      22 No contraception                                       85                    85
Lactational amenorrhea	2
Failure rate is less when methods are used correctly and consistently. (IUCD:  Intrauterine  Contraceptive  Devices;  CU-T: Copper-T;  LNG: Levonorgestrel; DMPA: Depot Medroxyprogesterone Acetate; NET: Norethisterone)


Table 36.2: MEC for contraceptive use (WHO/EPP/CDC}. Category	Use
1	No restriction of method and use.
2	Advantages of method use outweigh the risks. 3	Method risks of use outweigh the advantages. 4	Method possess unacceptably high health risk.

is wrapped with 314 mm2  of fine copper and each arm has a 33 mm2  copper bracelet. The sum of these is 380 mm2.   Two  strings  extend from the  base of the  stem.


Lower dose LNG-IUDs cause lesser rates of amenorrhea than the 52 mg LNG-IUD. The trailing strings attached to each device are: Tan for Mirena and Skyla; Blue for Lileta and Kyleena. Skyla and Lietta are approved for 3 years. Skyla and Kyleena  have a silver ring at the junction of their stem and arms.

Nonhormonal intrauterine devices: Cu-T 380A.
The Cu IUD is also the most effective form of postpartum contraception (see below).

Mode of action
Mechanism of antifertility effect of all the IUDs is not yet clear. They act predominantly in the uterine cavity and do not inhibit ovulation. They have both pre- and post­ fertilization effects to its eficacy and thus they are effective
immediatelyfollowing insertion. Probable factors are:
■    Biochemical   and  histological  changes   in  the endometrium: There is a nonspecific inflammatory reaction  along  with  biochemical  changes  in  the endometrium.  This  accumulates  throughout  the
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E
E
N ")









m Multiload 375	ll


Cu-T 380A	Levonorgestrel containing intrauterine system
ti	(LNG-I US)
Figs. 36.2A to D:  Commonly used intrauterine devices.


m   Skyla



uterine lumen, cervical canal and the fallopian tubes. This affects the function and viability of the gametes. Thus, it prevents fertilization, reduces chance of zygote formation and implantation. Lysosomal disintegration from the macrophages attached to the device liberates prostaglandins,  which  are  toxic  to  spermatozoa. Macrophages cause phagocytosis of spermatozoa.
■   Endometrial inflammatory response decreases sperm transport and impedes the ability of sperm to fertilize the ovum.
■   Copper devices: Ionized copper has got an additional local antifertility  effect by preventing blastocyst implantation  thro ugh  enzymatic  interference. Copper initiates the release of cytokines which are cytotoxic. Serum copper level is not increased. The copper ion impedes sperm transport and viability in the cervical mucus. These actions of IUD, prevent sperm to reach the tubes. So there is no fertilization.
■   Levonorgestrel-IUS {Mirena): It induces strong and uniform suppression of endometrium. Cervical mucus becomes very thick and scantly. It impedes sperm motility and  access to the upper genital tract. Anovulation and insufficient luteal phase activity has also been mentioned. PGN  also reduce tubal motility.  Serum progesterone level is not increased. The LNG has little
effect on the HPO axis. The serum E2 concentration are
not reduced and hence; ovulation occurs (Anovulation is more with 52 mg Vs 13.5 LNG-IUS).
The risk ofVTE is nil with the Cu IUCD; little with the LNGIUS.

Contraindications for Insertion of IUCD
■   Pregnancy or suspected pregnancy. ■   Undiagnosed genital tract bleeding.
■   Acute pelvic infection current or within 3 months.

■  Distortion of the shape of the uterine cavity as in fibroid or congenital uterine malformation.
■  Severe dysmenorrhea.
■   Known or suspected uterine or cervical neoplasia.
■   Postpartum  or  postabortal  endometritis  in  last 3 months or infected abortion.
■   Sexually Transmitted Infections (STis):  Current or within 3 months.
■   Trophoblastic disease.
■   Significant immunosuppression.

Additionally for Cu-T are:
■   Wilson disease. ■  Copper allergy.

For LnG-IUS are:
■   Hepatic tumor or hepatocellular disease (active). ■   Current breast cancer.
■   Severe arterial disease.

Time of Insertion
■  Interval (when the insertion is made in the intercon­ ceptional period beyond 6 weeks following childbirth or abortion): It is preferable to insert 2-3 days after the period is over. But it can be inserted any time during the cycle, provided she  is not pregnant. It can be safely inserted even during menstrual phase which has certain advantages (open cervical canal, distended  uterine  cavity,  less  cramp).  However, during lactational amenorrhea, it can be inserted at any time.
■   Postabortal:  Immediately  following  termination of pregnancy by suction evacuation or D and E, or following  spontaneous  abortion.  The  additional advantage of preventing uterine synechia can help in motivation for insertion.
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a

'J




:Q
I] Figs. 36.3A to F:  Withdrawal technique of insertion of CuT- . (Cl Uterocervical length is measured.



■   Cu-T 380A can be used as an emergency contraception up to 5 days following unprotected coitus.
Immediate postpartum:
■   Post-placental within  10 minutes after expulsion of placenta following vaginal delivery.
■   Intracesarean insertion  during  cesarean delivery, after removal of the placenta and before closure of the uterine incision.
■   Within 48 hours (MEC-1) after delivery before the patient is discharged from the hospital.
■   Extended postpartum/interval (between 48 hours to 4weeks: MEC-3) anytime after 4weeks (MEC-1).
■   Advantages are:  (a)  Safe and highly effective;  (b) immediate  action;  (c)  Long-term  protection;  (d) Special benefit to women having limited access or no access to postpartum care;  (e) Immediate return to fertility after removal; (f) No need of frequent visits and no further cost;  (g) High continuation rates and user satisfaction. Howeve1  the expulsion rate is high.
Criteria to exclude pregnancy: She has not had intercourse since her last normal menses; there is correct and consistant use of a reliable method of contraception; within the first 7 days of a normal menstrual period; not breastfeeding and is <4 weeks postpartum; fully breastfeeding, amenorrhoic, and <6 months postpartum; within 7 days post-abortion or miscarriage.
A negative pregnancy test, is reliable only if ?.3 weeks since the last episode of UPS!.

Methods of Insertion (Figs. 36.3 to 36.6)
■  Cu-T 200	■  Cu-T 380A (paragard)

Preliminaries
(1) History-taking and examinations (general and pelvic) to exclude any contraindication of insertion. (2) Patient is informed about the various problems, the device is shown to her and consent is obtained. (3) The insertion is done in the outpatient department, taking aseptic precautions without sedation or anesthesia. To reduce cramping pain ibuprofen [nonsteroidal anti-inflammatory drug (NSAID)] may be given (200-400 mg) 30 minutes before insertion. (4)  Placement of the device inside the inserter-the device is taken out from the sealed packet. The thread, the vertical stem and then the horizontal stem folded to the vertical stem are introduced through the distal end of the inserter. The device is now ready for introduction. "no touch" insertion method is preferred (see below).

Actual steps
(1) The patient empties her bladder and is placed in lithotomy position. Uterine size and position are ascertained by pelvic examination. (2) Posterior vaginal speculum is introduced and the vagina and cervix are cleansed by antiseptic lotion.


LNG-IUD


Inserter tube


 





..r----  Slider

Handle




Fig. 36.4:  Technique of insertion of multiload IUCD.	Fig. 36.5:  Insertion method of LNG-IUS.
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Fig. 36.6:  LNG-IUS insertion device. Different parts of the device are shown.


(3) The anterior lip of the cervix is grasped by Allis forceps. A sound is passed through the cervical canal to note the position of the uterus and the length of the uterine cavity. The appropriate length of the inserter is adjusted depending on the length of the uterine cavity. (4) The inserter with the device placed inside is then introduced through the cervical canal right up to the fundus and after positioning it by the guard, the inserter is withdrawn keeping the plunger in position. Thus, the device is not pushed out of the tube but held in place by the plunger while the inserter is withdrawn (withdrawal technique in Figure 36.3). (5) The excess of the nylon thread beyond 2-3 cm from the external os is cut. Then the Allis forceps and the posterior vaginal speculum are taken off. 'No-touch' insertion technique includes:  (i) Loading the IUD in the inserter without opening the sterile package. The loaded inserter is now taken out of the package without touching the distal end. (ii) Not to touch the vaginal wall and the speculum while introducing the loaded IUD inserter through the cervical canal.
■   Multiload Cu-375: The applicator with the device is just to be taken out of the sealed packet in a 'no-touch' method and the same is pushed through the cervical canal up to the fundus of the uterus. The applicator is then withdrawn (Fig. 36.4).
■   LNG-IUS: The details of insertion are to be followed as in the instruction package (Fig. 36.5).

Principal steps
The initial steps are the same as in Cu-T 380A.
Sterile package is opened up. The arms of the device should be kept horizontal. The slider is pushed up, to draw the IUCD within the insertion tube.
■   The uterocervical length is measured by the uterine sound.
■   The flange on the inserter tube is positioned from the IUCD tip according to this uterocervical length.
■  The inserter tube with the device is gently inserted within the uterus, until the flange is at 1.5-2 cm from the external os.
■  The arms of the device are then released by pulling the slider back to the  raised  white line on the handle. To hold  this position for about 20-30 seconds to allow the arms to open fully.
■   The inserter is then gently guided into the uterine cavity until its flange touches the cervix (Fig. 36.6).
■   The  device  is released  by  holding  the inserter  firmly in position and  pulling the slider back all the way.  Fundal placement is ideal.
■   The threads are released automatically. The inserter is then removed slowly.

■   The threads are then trimmed preserving 3 cm length outside the cervix (same as in Cu-T 380A).

Instructions to the patient
The possible symptoms of pain and slight vaginal bleeding should be explained. The patient should be advised to feel the thread periodically by the finger. The patient is checked after 1 month and then annually.

Complications Immediate
■   Cramp-like pain: It is transient  but, at times, severe and usually lasts for half to 1 hour.  It is relieved by analgesic (ibuprofen) taking before insertion or antispasmodic drugs.
■   Syncopal attack: Pain and syncopal attack are more often found in nulliparous or when the device is large enough to distend the uterine cavity.  This could be problematic in patients with cardiac disease.
■   Partial or complete perforation: It is due to faulty tech­ nique of insertion but liable to be met within lactational period when the uterus remains small and soft.

Remote
■   Pain: The pain is more or less proportionate to the degree of myometrial distension. A proper size of the device may minimize the pain.
■   Abnormal  menstrual bleeding:  The excessive  bleeding involves increased menstrual blood loss, prolongation of duration of period and intermenstrual bleeding. The patient may become anemic especially who is already anemic. Iron supplement is advocated. Tranexamic acid may be given for short-term relief.
Menstrual loss  is much  less with  the use  of third­ generation IUDs {p. 503).
Women using LNG-IUS have less (60%) blood loss. Nearly 50% of women develop amenorrhea and 25% have oligomenorrhea after 24 months of use.
■   Pelvic Inflammatory Disease (PID): The risk of developing PID with the use of current devices, is not increased. Modern IUDs have monofilament (not braided) strings that do not increase the risk of infection. Asymptomatic, low risk women do not need  additional  screening  prior  to IUD  insertion (ACOG-2017). Infections with gonorrhea,  Chlamydia and rarely with actinomyces are seen.  Women at risk of STis should  be screened  either  before or  at  the  time  of  IUD insertion (CDC-2015). Women with existing infection like purulent vaginal discharge, adnexal tenderness or cervical
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motion tenderness, laboratory testing should be done and IUCD insertion is  delayed.  Newer IUDs  reduce the risk. Women with IUCD in situ, diagnosed with pelvic infection, removal of IUCD is advised if there is no response to treatment even after 72 hours.
Pain, Abnormal Uterine Bleeding (AUB) and PID are the main factors related to its discontinuation (10-15%).
■   Spontaneous expulsion: Usually occurs within the first month
following insertion,  more commonly during the period, at times, unnoticed by the patient. Failure to palpate the thread which could be felt before, is an urgent ground to report to the physician. The expulsion rate is about 5%. The rate is, however, more following postabortal or puerperal insertions. The expulsion rate is markedly reduced in the successive years. The newer IUDs have got less expulsion rate.
■  Perforation  of  the  uterus:  It is rare  and  the  incidence is  about  1 in  1,000 insertions  most  commonly  seen  in breastfeeding women. Most perforations occur at the time of insertion but migration may also occur following initial partial perforation with subsequent myometrial contractions. It is, however, less common when the device is introduced by the withdrawal technique.
■  Diagnosis of uterine perforation: (1) Nonvisibility of the threads through the external os and the appearance of pelvic symptoms after a long asymptomatic period are suspicious. (2) Negative findings on exploration of the  uterine  cavity  by a  probe  is  suggestive.  (3) Ultrasonography can detect the IUD in abdominal cavity and is better than radiography. (4) Plain X-ray, anteroposterior and lateral view, following introduction of a radiopaque probe (uterine sound) into the uterine cavity, is conclusive. (5) The device is found away from the opaque shadow placed in the uterine cavity, if it has perforated the uterine wall (Fig. 36.7). Management of missing thread is discussed below.
















Fig. 36.7:  Plain X-ray of the pelvis with an uterine sound placed inside the uterine cavity-the displaced Intrauterine Contraceptive Device (IUCD) seems inside the uterine cavity with Anteroposterior (AP) view. Lateral view is needed for confirmation.
(Courtesy:  Dr  Swati  Shirodkar,  Head,  Department of Obstetrics and Gynecology, MGM Medical College, Aurangabad)


Copper Device
A copper-bearing device induces an intense local inflam­ matory reaction with adhesions with the surrounding structures. Thus, as soon as the diagnosis is made, it is to be removed by laparoscopy or laparotomy.

Pregnancy
The pregnancy rate with the device in situ is rare. Lowest pregnancy rates are observed with Cu-T 380A (0.8-HWY) and  LNG-IUS  (0.2-HWY).  When  pregnancy  occurs with a device in situ,  there is risk of ectopic pregnancy (0.02%). IUD can thus prevent a uterine but not an ectopic pregnancy.
Third generation of IUDs like Cu-T 380A  and LNG­ IUS give some amount of protection against an ectopic pregnancy. IUCDs do not increase the viral shedding or reduce the antiretroviral therapy efficacy (ACOG, 2012).
■  Management of a pregnant woman with device in situ: If the thread is visible through the cervix it is best to remove the device. This will minimize complications like miscarriage, preterm labor, sepsis, placenta  previa,  abruption,  cesarean delivery,  low birth weight baby, including malformations. However, if the thread is not visible,  it is better to counsel the  patient about the risks involved in continuing pregnancy.  Pelvic ultrasound  must  be  carried  out to  locate  the  pregnancy.  When  the  pregnancy  is undesired,  manual  vacuum  aspiration  can be  done to remove the pregnancy and the device. The device is  expected  to be  expelled  spontaneously  with  the delivery of the placenta.
Indications for removal of IUDs
♦   Persistent excessive regular or irregular uterine bleeding. ♦   Flaring-up of salpingitis.
♦   Perforation of the uterus.
♦    IUD has come out of place (partial expulsion). ♦   Pregnancy occurring with the device in situ.
♦   Woman desirous of a baby. ♦   Missing thread.
♦   One year after menopause.
♦   When effective lifespan of the device is over.
IUD removal is simple and can be done at any time. It is done by pulling the strings gently and slowly with forceps.
■  Missing threads:  The  thread  may not be  visible through the cervical os due to-(a)  Thread coiled inside; (b) Thread torn through; (c) Device expelled outside unnoticed by the patient; (d) Device perforated the uterine wall and is lying in the peritoneal cavity, and (e) Device pulled up by the growing uterus in pregnancy.
Methods of identfication
Pregnancy is to be excluded first. Alternate contraceptive advice is given:
♦   Ultrasonography  (TVS  and  TAS)  can  detect  the  IUD either within the uterine cavity or in the peritoneal cavity (if perforated) {Fig. 36.8).  3-D TVS is more informative.
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Fig. 36.8:  Ultrasonogram showing the Cu-T inside the uterine cavity, Thread was missing in this case.

When sonography is inconclusive of the device is not seen within the uterus, a plain X-ray of the abdomen and pelvis is to be done. Imaging with CT or MRI is rarely needed.
♦   Hysteroscopy can be used for direct visualization of the uterine cavity and it could be removed simultaneously (Fig. 36.9),
♦   Sounding the uterine cavity may be done by a probe.
♦   If negative, plain X-ray is done after introducing a radio­ opaque probe (uterine sound) into the uterine cavity. This will not only reveal the presence or absence of the device but also its existence outside in the abdominal cavity,
Removal
♦   Device inside the uterine cavity: It can be removed by any of the following methods.
•  With a specially designed blunt hook (Dutta's Textbook Gynecology, Ch. 38, Fig. 38.41, p. 544),
•  Hysteroscopically under direct vision (Fig. 36.9). •  Uterine curette.
•  Artery forceps.
♦   Outside  the  uterus  but  inside  the  abdominal  cavity: (a) Laparoscopy; (b) Laparotomy (rarely).
















Fig. 36.9:  Hysteroscopic view of IUCD in uterine cavity, The threads are coiled inside.

Advantages
■   Inexpensive: Cu-T distributed free of cost through Government channel.
■   Simplicity in techniques of insertion and most cost effective of all methods,
■   Prolonged contraceptive protection after insertion (5-10 years) and suitable for the rural population of developing Countries.
■   Systemic side effects are nil. Suitable for hypertensives, breast­ feeding women and epileptics.
■   Reversibility to fertility is prompt after removal; failure rate-0.1-2/HWY,
■   Risk of ectopic pregnancy is significantly reduced (Cu-T 380A and LNG-IUS: 0.02 HWY).
■   Risk of PIO is reduced, anemia is improved.
■   Noncontraceptive benefits, especially with LNG-IUD:
• Significant reduction in menstrual blood loss, menorrhagia, dysmenorrhea, and premenstrual tension syndrome (PMS),
•  It can be used in the treatment of endometrial hyperplasia, adenomyosis, endometriosis, and uterine leiomyomas.
■   Safety and advantages of LNG-IUS:
• Use is associated with reduction in the risk of endometrial and cervical carcinoma,
•  LNG-IUS-can be used as a fertility sparing treatment in early stage endometrial carcinoma.
• Safe and as effective as an alternative to sterilization method,
•  Higher level of user satisfaction.
• It can be used as an alternative to hysterectomy for menor­ rhagia, Dysfunctional Uterine Bleeding (DUB).
• It  provides  excellent  benefits  of  Hormone  Replacement Therapy (HRT) when used over the transition years of repro­ duction to perimenopause.
■   Disadvantages of third generation of IUDs •  Expensive (LNG-IUS).
• Amenorrhea (5%).
• Malpositioning with long duration of use may cause pregnancy (failure) or expulsion,

Advantages of third generation ofIUDs
Cu-T 380A, multiload-375 and levonorgestrel-IUS.
♦   Higher efficacy with lowest pregnancy rate (less than one per 100 women every year).
♦   Used as LARC with longer duration of action (5-10 years).
♦   Low expulsion rate and fewer indications for medical removal (Box36.l).
Long-Acting Reversible  Contraceptions  (LARC)  are designed to be used for at least I year. LARC methods are cost effective compared to shorter acting methods, Commonly 2 types of IUD are available: (a) Nonhormonal and (b) Hormonal. There are four types of LNG-IUD which are used: LNG-IUD 52 mg (Mirena and Lileta): Both measure 32 mm x 32 mm and initially release 20 pg LNG daily. Mirena is approved for 5 years and the Liletta is approved for 6 years but both are likely to be effective for 7 years. Non-contraceptive benefits are also there, WHO has grouped methods into efficacy tiers (Table 36.2), Intrauterine devices and the implants are found to in the top tier. These are also known as for Long-Acting Reversible Contraception (LARC) (Read more Dutta's Clinics in Gynecology, Ch. 29).
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SUMMARY OF IUD
Intrauterine contraceptive device is a safe and widely acceptable reversible method of contraception for spacing of births. Amongst
many, either a copper impregnated device like Cu-T, Multiload 375 or a hormone-releasing device like LNG-IUS is commonly used. Its mode of action: It produces nonspecific biochemical and histological changes in the endometrium and ionized copper has got spermolytic and gametotoxic effects. LNG-I US induces uniform suppression of endometrium and produces very scanty cervical mucus. Both copper and LNG-IUS can be offered to young or nulliparous women. Symptomatic women with IUCDs should be treated with an antibiotic regimen (CDC, 2015) till she is symptom free. Otherwise the device should be removed (<72 hours).  The device can be introduced in the interval period or following abortion or following childbirth.  The  introduction is an outdoor procedure and can be done even by a trained paramedical  personnel  without anesthesia.  The technique employed is 'withdrawal' in Cu-T. The
immediate complications include cramp-like pains or even syncopal attacks. The delayed complications include pelvic pain, menstrual irregularities, expulsion of the IUD or even perforation of the uterus. Complications are much less with third generation of IUDs. The indications of its removal are missing threads, persistent pelvic pain, menorrhagia, pregnancy, displacement of the device and flaring up of pelvic infection. Multiload 375 is replaced after 5 years, Cu-T 380A after 10 years and LNG-IUS after 5 years. The failure rate is about 0.5-2 per HWY. Devices Jess than 300 mm2 of copper have higher failure rate. Copper device can also be used as postcoital contraception and following synechiolysis.




►  Modes of antifertility effects of IUCDs are: (a) Nonspecific inflammatory reaction along with biochemical (gametotoxic) changes in the endometrium; (b) Copper devices release ionized copper that prevents blastocyst implantation; (c) LNG-IUS-suppresses endometrium, as it makes cervical mucus scanty.
►  The introduction of IUCDs (Cu-T, multiload) is an OPD procedure without anesthesia taking full aseptic precautions. 'no touch' insertion technique is preferred.
►  Intrauterine Contraceptive Devices (IUCDs): (a) This is an effective method of contraception with failure rate of 0.5-2 HWY; (b) It is also the most effective method of emergency contraception; (c) It can be used by nulliparous women; (d) IUCDs containing <300 mm2 copper have higher failure rate; (e) Irregular and heavy bleeding may be the side effects and the reason for removal; (f) Third generation IUCDs have higher efficacy and reduced side effects; (g) Risks of ectopic pregnancy is also reduced.
►  The contraindications to insertion of IUD are:  PID,  suspected pregnancy, DUB or suspicious cervix.  The failure (pregnancy) rate is about 0.5-2 HWY. There is risk of ectopic pregnancy 1-2%. Third generation IUDs have minimal side effects and lowest pregnancy rate.
►  Immediate complications of IUDs include pain, syncopal attack, and uterine perforation. Remote complications include-pain, abnormal uterine bleeding, pelvic infection, spontaneous expulsion or even perforation of the uterus.
►  Indications of removal of IUD are-excessive uterine bleeding, flaring up of pelvic infection, uterine perforation, pregnancy, missing thread, and patient desirous of a baby.
►  There are many reasons for missing threads and management depends on whether it is within the uterine cavity or within the peritoneal cavity.
►  Apart from contraception, the IUD is used as an emergency contraception and following synechiolysis.
►  The replacement time for Cu-T 2008 is 4 years, multiload 250-3 years, Cu-T 380A-1 O years, multiload 375-5 years and LNG-IUS is 5 years.
►  LnG-IUS has got many noncontraceptive health benefits. It is a very safe and effective method for prolonged use.


STEROIDAL CONTRACEPTIONS

Enovid (norethynodrel 10 mg and mestranol 0.15 mg) was used in the first contraceptive field trial in Puerto Rico in 1956 by Pincus and his colleagues. Currently, 30 µg dose of estrogen has been reduced to 20 µg or even 10 µg to minimize the side effects of estrogen without reducing the efficacy. Types  of steroidal contraceptives have been discussed in Flowchart 36.2.

COMBINED HORMONAL CONTRACEPTIVES (CHC)

The combined oral hormonal contraceptives (pills) is the most effective reversible method of contraception.  Other forms of CHC include:• Combined Vaginal Ring (CVR) [Releasing EE: 15 mcg/day + etonogestrel: 120 mcg/day] and• Combined Transdermal  Patch   (CTP)   [Releasing  EE:  40  mcg/day   + norelgestromin:   203 mcg/day].  The contraceptive efficacy

and side effect of all CHC's are similar. In the combination pill, the commonly used progestins are either levonorgestrel, or norethisterone,  or desogestrel and the estrogens are principally confined to either ethinylestradiol or mestranol (3-methyl ether of ethinylestradiol). Currently, 'lipid friendly' third-generation progestins, namely desogestrel, gestodene, norgestimate are available. Some of the preparations available in the market are mentioned in Table 36.3. Only Mala-N is distributed through Government channel free of cost (Fig. 36.10).
Fourth  generation:  Drospirenone which is an analog  of spironolactone  is  used  as  progestin.  It  has  antiandrogenic and antimineralocorticoid action.  It causes retention of K+ (hyperkalemia) and reduces water retention. So drospirenone should not be used in patients with renal,  adrenal or hepatic dysfunction.
Serum potassium should be monitored when the women is on any other drug to cause potassium retention (NSAIDs, ACE inhibi­ tors, potassium sparingdiuretics, heparin, aldosterone antagonists).






I






• Oral

Chapter 36: Population Dynamics and Control of Conception     ED -­ Flowchart 36.2: Types of steroidal contraceptives.

STEROIDAL CONTRACEPTIVES
I
I
•
I
•
•
l
I
I	•   I	Parenteral	I   •	Device	I  I	Patch	I
I
I
I
lnjectables	Implant	Transdermal
• DMPA	• lmplanon.	(nestorone)
• NET-EN	• Norplant-II.
• Combined (ones a	• LNG rod.
month injection)



•
Combined preparations • Monophasic.
• Biphasic. • Triphasic.
• Emergency (postcoital).

•
Single preparations
• Progestin-only pill
(minipill).
• Estrogen only
(emergency).




I

•
IUD
(LNG-I US)




I



  Vaginal ring • LNG ring.
• Combined (estrogen and
progesterone) ring.




I

•
Transcervical • Essure




I


(DMPA: Depot Medroxyprogesterone Acetate; NET-EN: Norethisterone Enanthate; LNG: Levonorgestrel; LNG-IUS: Levonorgestrel-lntrauterine System; IUD: Intrauterine Devices)

TABLE 36.3: Some of the oral contraceptives and their composition.


Commercial names
1. Mala-n (Government of India) 2. Mala-D
3. Loette (Wyeth)
4. Yasmin (Schering)


Progestins (mg) Levonorgestrel (0.15) Levonorgestrel (0.15) Desogestrel (0.15)
Drospirenone 3 mg

Composition
Estrogen (µg) Ethinyl estradiol (30) -do-
Ethinyl estradiol (20)
Ethinyl estradiol (30)


No. of tablets
21 + 7 iron tablets 21 + 7 iron tablets 2
21

Depending on the amount of Ethinyl Estradiol (E) and the types of progestin (P) used. Pills are defined as: 1st generation-with E 50  Lg or more; 2nd generation-with E 20-35 µg and Pas levonorgestrel or norgestimate (active metabolite: Norelgestromin); 3rd generation-with E 20-30  Lg and Pas desogestrel (active metabolite: Etonogestrel) or gestodene; 4th generation-E as third generation, with Pas drospirenone, dienogest or nomegestrol. Low dose pills have E less than SO mcg.













Fig. 36.10:  Some commonly used oral contraceptives.


Mode of Action
The probable mechanisms of contraception are:
■  Inhibition of ovulation: Both the hormones synergistically act  on  the  Hypothalamopituitary  (HP)  axis.  Estrogen suppresses  GnRH,  Follicle-Stimulating  Hormone  (FSH) and  prevents follicular  growth and  progestins  suppress Luteinizing Hormone (LH) and prevent ovulation. The release of  Gonadotropin-Releasing  Hormones  (GnRH)  from  the


hypothalamus is prevented through a negative feedback mechanism. There is thus no peak (pulsatile) release of FSH and LH from the anterior pituitary. So follicular growth is either not initiated or if initiated, recruitment does not occw: There is no ovulation.
■   Producing static endometrial hypoplasia: There is stromal edema, decidual reaction and regression of the glands making endometrium nonreceptive to the embryo.
ll Chapter 36: Population Dynamics and Control of Conception

■  Alteration of the character of the cervical mucus (thick, viscid, and scanty) so as to prevent sperm penetration.
■   Probably interferes  with  tubal  motility  and  alters  tubal transport.  Thus,  even  though  accidental  breakthrough ovulation occurs, the other mechanisms prevent conception.
Estrogen inhibits FSH rise and prevents follicular growth It is also useful for better cycle control and to prevent breakthrough bleeding.
Progestin: Anovulatory effect is primarily by inhibiting LH surge. It is also helpful to counteract the adverse effects of estrogen on the endometrium (endometrial hyperplasia and heavy withdrawal bleeding). It is also responsible for changes in the cervical mucus (vide supra).

Selection of the Patient
History and general examination should be thorough, taking special care to screen cases for contraindications (headache, migraine). Examination of the breasts for any nodules, weight, and blood pressure are to be noted.
Pelvic examination to exclude cervical pathology, is mandatory. Pregnancy must be excluded.
Cervical cytology (HPV screening) to exclude abnormal cells, preferably to be done. Thus, any woman of reproductive age group without any systemic disease and contraindications listed, is a suitable candidate  for combined pill therapy (Table 36.4). Growth and development of the pubertal and sexually active girls are not affected by the use of 'pill'.

How to Prescribe a Pill?
Patient instruction: New users should normally start their pill packet on day one of their cycle. One tablet is to be taken daily preferably at bed time for consecutive 21 days. It is continued for 21 days and then has a 7 days break, with this routine, there is contraceptive protection fom thefirst pill. Next pack should be
r


started on the eighth day, irrespective of bleeding (same day of the week, the pill finished). Thus, a simple regime of "3 weeks on and 1 week off" is to be followed. Packing of 28 tablets, there should be no break between packs. Seven of the pills are dummies and contain either iron or vitamin preparations. However, a woman can start the pill up to day 5 of the bleeding. In that case, she is advised to use a condom for the next 7 days. The pill should be started on the day after abortion. Following childbirth in nonlactating woman, it is started after 3 weeks, and in lactating woman, it is to be withheld for 6 months (p. 509).
Follow-up: The patient should be followed up based on her symptoms. The patient above the age 35 should be checked more frequently.
Missed pills: Normally, there is return of pituita1y and ovarian follicular activity during the Pill-Free Interval (PFJ) of 7 days. Breakthrough ovulation may occur in about 20% cases during this time. Lengthening of Hormone Free Interval (HFI) due to omissions, malabsorption, or vomiting either at the start or at
the end of a packet, increases the risk of breakthrough ovulation and, therefore, pregnancy.

Management
When a woman forgets to take one pill (late up to 24 hours), she should take the missed pill at once and continue the rest as schedule. There is nothing to worry.
When she misses two pills or more she should take the most recent missed pill immediately and then continue the rest as scheduled. Extra precaution has to be taken for next 7 days either by using a condom or by avoiding sex. Alternatively, a new pack can be started and a barrier method to be used additionally for a week. Failure of withdrawal bleeding during the pill free interval, pregnancy should be excluded with medical tests. CHCs are not teratogenic when taken accidentally in early pregnancy.


Table 36.4: Medical Eligibility Criteria for contraceptive use (WHO/FRM/FPP) (p. 498, Table 36.2). Combined Oral Contraceptives (COCs)
Indications of COCs	Contraindications of COCs

No restriction of use (WHO Category-1)
•  Age: Menarche to 40 years. •  Postabortion.
•  Anemia (iron deficiency, malaria).
•  HIV or AIDS (additional to condom use). •  GTN following normal hCG level.
•  History of ectopic pregnancy.
•  Endometriosis, uterine fibroid, ovarian or endometrial cancer.
•  Dysmenorrhea, DUB.
•  Pelvic inflammatory disease. •  Epilepsy.
•  Thyroid disease. •  Varicose veins. •  Tuberculosis.
•  Benign breast disease.


Relative (WHO Category-2 and 3)
A. WHO Category-2  (advantages outweigh the risks):
• Age ;,40 years.
• Smoker <35 years. • History of jaundice. •  Mild hypertension. •  Gallbladder disease. • Diabetes.
• Sickle cell disease. • Headache.
• Cancer cervix or CIN.
B. WHO   Category-3   (risks   outweigh   the advantages):
• Unexplained vaginal bleeding. • Hyperlipidemia.
• Liver tumors (benign).
• Breastfeeding (postpartum 6 weeks to 6 months).
• Heavy smoker (> 20 cigarettes/day). • Past breast cancer.


Absolute (WHO Category-4)
A. Circulatory diseases (past or present): • Arterial or venous thrombosis.
• Severe hypertension. • History of stroke.
• Heart disease: Valvular, ischemic. • Diabetes with vascular
complications.
•  Migraine with focal neurologic symptoms (aura).
B. Diseases of the liver:
• Active liver disease, jaundice. •  Liver adenoma, carcinoma.
C. Others:
•  Pregnancy
• Breastfeeding (postpartum 6 weeks). • Major surgery or prolonged
immobilization.
• Estrogen-dependent neoplasms, e.g., breast cancer.

(GTN:  Gestational  Trophoblastic  Neoplasia;  CIN:  Cervical  lntraepithelial  Neoplasia;  HIV:  Human  Immunodeficiency  Virus;  AIDS:  Acquired Immunodeficiency Syndrome; hCG: Human Chorionic Gonadotropin; DUB: Dysfunctional Uterine Bleeding)
Chapter 36: Population Dynamics and Control of Conception    Ea

Drug Interactions
Effectiveness of some drugs (aspirin, oral anticoagulants, oral hypoglycemics, lamotrigine) are decreased and that for some other drugs (beta blockers, corticosteroids, diazepam, aminophylline) are increased by oral contraceptives(details on p. 513).

Additional Contraception
To ensure 100% efficacy, additional mechanical contraceptives (usually condom) are to be used in the following circumstances:
■  When  broad-spectrum   antibiotics   like   ampicillin, ciprofloxacin, tetracycline, doxycycline are used-as they impair the absorption of ethinyl estradiol.
■  When enzyme-inducing drugs are used, e.g., ( a) Barbiturates; (b) All antiepileptic drugs except sodium valproate and clon­ azepam; (c) Rifampicin; (d) Ketoconazole; (e) Griseofulvin; (f) Protease inhibitor (ritonavir); and (g) Nevirapine-under such circumstances, high dose preparations (ethinyl estra­ diol of 50  1g or more) are to be used to counter-balance the increased liver metabolism.
The indications for withdrawal of the pill are-(a) Severe migraine; (b) Visual or speech disturbances; (c) Sudden chest pain; (d) Unexplained fainting attack or acute vertigo; (e) Severe cramps and pains in legs; (f) Excessive weight gain; (g) Severe depression; (h) Prior to surgery (it should be withheld for at least 6 weeks to minimize postoperative vascular complications), and (i) Patient wanting pregnancy.

Continuous Cycle and Extended Use of COCs
Extended cycle or continuous regimens: Contain 84 days of active pills followed by 7 days of Hormone Free Interval (HFI). Withdrawal bleeding is only four times a year. Any monophasic pill may be used in this manner. Failure rate is also Jess. This generally decreases or eliminates withdrawal bleeding. Extended use preparations also improve menorrhagia, dysmenorrhea, endometriosis and chronic pelvic pain.
Return of fertility: The suppressive effects on H-P-O axis disappear quickly following stoppage of low dose COCs. Normal endocrine function returns. Ovulation returns within 3 months of withdrawal of the drug in 90% cases. Women who conceive inadvertently while taking COCs, there is no risks of fetal congenital malformations.
Withdrawal bleeding: It is bleeding that is seen during the hormone free interval, whereas bleeding that occurs during the time when active pills are being taken is called breakthrough bleeding. Breakthrough bleeding is due to insufficient estrogen to support the endometrium.
How Long can the Pill be Continued?
Potential benefits of pills are greater when compared to risks, in a well-selected individual. A woman who does not smoke and has no other risk factor for cardiovascular disease, may continue the pill (with careful monitoring) until the age of 50 years. This offers the dual advantages of effective contraception and HRT. However, for spacing of births, use of 3 to 5 years is considered enough and safe.

General and Metabolic Effects of COCs
The combined preparations containing estrogen and progestin have got a wide range of metabolic activities which affect almost all the systems of the body. The changes are almost similar to


those of pregnancy and almost completely revert back to normal after the drug is withdrawn. The effects are related either to the estrogen (OGN) or to the progestin (PGN) or to both (OGN + PGN) of the compounds.

Health Benefits of Combined Oral Contraceptives (COCs)
■   Contraceptive benefits: (a) Protection against unwanted pregnancy(failure rate-0.1 per 100 women years); (b) Con­ venient to use; (c) Not intercourse related; (d) Reversibility; and (e) Improving maternal and child health care.
■  Noncontraceptive health benefits: Improvement of menstrual abnormalities-(1) Regulation of menstrual cycle (Box 36.2); (2) Reduction of dysmenorrhea (40%);  (3) Reduction of menorrhagia (50%); (4) Reduction of PMS; (5) Reduction of Mittelschmerz syndrome; (6) Protection against iron-deficiency anemia. Protection against health disorders;  (7) PIO (thick cervical mucus); (8) Ectopic pregnancy; (9) Endometriosis; (10) Fibroid uterus; (11)  Hirsutism, acne and PCOD; (12) Functional ovarian  cysts;  (13)  Benign  breast  disease;  (14) Osteopenia  and  postmenopausal  osteoporotic  fractures; (15) Autoimmune disorders of  thyroid;  (16) Rheumatoid arthritis; (17) Increases bone mineral density. Prevention of malignancies; (18) Endometrial cancer (50%); (19) Epithelial ovarian cancer (50%); (20) Colorectal cancer(40%).
Adverse Effects of COCs Minor Complications
The minor complications or ailments are:
■   Nausea, vomiting, headache (OGN) and leg cramps (PGN): These are transient and often subside following continuous use for 2-3 cycles.
■  Mastalgia (OGN + PGN): Heaviness or even tenderness in the breast is often transient.
■  Weight gain (PGN): Though progestins have got an anabolic effect due to its chemical relation to testosterone, use of low­ dose COCs does not cause any increase in weight.
■   Chloasma (OGN) and acne (PGN): These are annoying for cosmetic reasons. Low-dose oral contraceptives improves acne as levonorgestrel preparations are less androgenic.
■  Menstrual abnormalities: Breakthrough Bleeding (BTB): It is commonly due to subthreshold blood level of hormones. Other causes of breakthrough bleeding in pill takers are: (a)  Disturbance of drug  absorption-diarrhea,  vomiting; (b)  Use of enzyme inducing drugs (mentioned earlier), missing  pills,  use  of  low  dose  pills;   (c)  Pregnancy complications (miscarriage); (d) Diseases-cervical ectopy or  carcinoma.  Usually,  it settles  after 3-4 cycles  when



Health benefits of COCs ■   Highly effective.
■   Good cycle control.
■   Well-tolerated in majority.
■   Additional health benefits are many.
■   Low-dose pill with 'lipid friendly' progestins further reduces the risk.
■   Extended regimens are available. ■   Return of fertility rate is prompt.
Failure rate-0.1 (HWY)
r-ED Chapter 36: Population Dynamics and Control of Conception there is no other specific cause for BTB. Exogenous estrogen (conjugated estrogen  1.25 mg or estradiol 2 mg) given daily for 7 days can control the bleeding. Doubling up the active pills for 2-3 days, or until bleeding stops, is helpful. A pill containing higher dose of estrogen, with different progestin  could be helpful.  BTB is not  associated  with any increased failure rate. CVR has better cycle control. Hypomenorrhea (PGN): It is of little significance although disturbing to the patient. It is due to the local endometrial changes.  Menorrhagia  (OGN):  It is usually pre-existing and use of compounds with progestin preponderance is helpful. Amenorrhea (OGN or PGN): Postpill amenorrhea of more than 6 months duration occurs in less than 1 % cases. The association is casual not causal. It is usually more in women with pre-existing functional menstrual disorders. Spontaneous resumption of menstruation occurs in 6 months for majority of cases. A refractory case (>6 months) should be investigated as a case of secondary amenorrhea.
.
"
11   Libido (PGN):  Libido may be diminished probably due to d1yness of the vagina. More often, it may either remain static or, at times, may even increase due to loss of fear of pregnancy.
■   Leukorrhea:  It  may  be due to excessive cervical mucus secretion  (OGN)  or due to increased preponderance of monilial infection (OGN + PGN).
Major Complications
■  Depression:  Low-dose  estrogen  preparations  are  not associated with depression.
11  Hypertension (OGN): Current low dose COCs rarely cause significant hypertension. Pre-existing hypertension is likely to be aggravated. Changes are seen only in systolic but not in diastolic blood pressure. The effect on blood pressure is thought to involve the renin-angiotensin system. There is marked increase in plasma angiotensinogen. The changes, however, reverse back to normal 3-6 months after stoppage of pill.
■   Vascular complications (OGN):
(A) Venous Thromboembolism (VTE): The overall risk is to the extent of 3-4 times more than the non-users. Pre­ existing hypertension, diabetes, obesity  thrombophilias (inherited  or  acquired)  and  elderly  patient  (over  35, especially with smoking habits) are some of the important risk factors. Ethinyl estradiol used with a dose of 20 µg in the pill markedly reduce the incidence. Current studies estimate the annual number of nonfatal VTE per 100,000 users as: no COC use= 4, second-generation COC= 10, COC-containing desogestrel and gestodene =  30, pregnancy=  >100. The absolute  risk  is  very  small  compared  to  pregnancy. The most important risk factor is  genetic thrombophilia {factor  V Leiden mutation).  This is rare in Asians (0.4%) compared to Caucasian (5%). Lowest risk of VTE  is with COC containing LNG/NET/Norgestimate. Increased rate ofVTE is seen with other CHC like CTP/CVR.
(B) Arterial thrombosis: The high-risk factors for myocar­ dial infarction and stroke (ischemic and hemorrhagic) are hypertension, smoking habit, age over 35 and diabetes. Women with multiple risk factors for cardiovascular disease generally should not use COCs.
■  Cholestatic jaundice: Susceptibility is increased in women with previous  history of idiopathic recurrent  jaundice in pregnancy or hepatitis.






■  Neoplastic  risks  and  the  benefits:  Combined  Oral Contraceptives  (COCs)  reduce  the  risk  of epithelial ovarian (50% ..I-) and endometrial (50% .I-) carcinoma. This protective effect persists for 10-15 years even after stopping the method following a use of 6 months to 1 year.  There is reduction in colorectal carcinoma (20%).
Breast cancer: COCs use increases the risk of breast cancer by 25% and the risk disappears after cessation of use. The absolute risk is low. However COC can be prescribed to women with a family history of breast cance,:
Cervical cancer: COC increase the risk of cancer cervix with increasing duration of use (>5 years). It is no longer a risk factor after 10 years of stopping. Adenocarcinoma of the cervix is more compared to squamous cell. However, pill users should have regular HPV-DNA and cervical cytology screening. No increased risk ofhepatocellular adenomas have been found with low dose preparations. It gives protection against benign cystic breast disease and cystic ovaries.
■   Death:  Risk of death for a woman using COCs is about 1.5/100,000. It is significantly low.
General and Metabolic Effects
Carbohydrate (PGN): Progestins impair glucose tolerance promoting insulin resistance  and  hyperglycemia.  This was observed in preparations containing 150 µg or more levonorgestrel. Low-dose COCs have no effect on insulin, HbAlC, and fasting glucose levels. Protein (OGN): Estrogen has got some stimulatory effect on the hepatic secretion of many proteins. Fibrinogen and other clotting factors level rise in direct proportion to the estrogen. This may cause thrombosis. The level of sex hormone-binding globulin (SHBG) is increased. Lipid (OGN): Plasma lipids and lipoproteins are increased. Total cholesterol and triglycerides are increased. Low dose estrogen increases High-Density Lipoprotein (HDL) cholesterol and decreases Low-Density Lipoprotein (LDL) cholesterol thereby exerts its protective effect against atherosclerosis. Progestins, howeve,; decrease HDL cholesterol and increase LDL cholesterol thereby promote heart disease. Preparations with more selective, lipid friendly, and third generation progestins namely desogestrel, gestodene or norgestimate, HDL level is somewhat elevated. However, most changes are within the normal range
and not clinically relevant. Vitamins and minerals: Vitamin B6, B12, folic acid, calcium, manganese, zinc, and ascorbic acid levels are decreased while vitamins A and K levels are increased.
Effects on Organs
■   Hypothalamopituitary  axis:   Both  FSH  and  LH  levels remain low as found in early proliferative phase and remain throughout the cycle at such static low level.
■   Ovary: Ovarian function remains quiescent with occasional evidence of breakthrough ovulation. There is evidence of fibrosis, progressive wastage of unripe ova with advancing age without  evidence of corpus luteum.  The endogenous hormones remain static at a low level.
■  Endometrium (PGN): Stromal edema, decidual reaction and glandular exhaustion out of depletion of glycogen are more or less constant findings.
■   Cervix (PGN + OGN): Increased glandular hyperplasia and downgrowth of the endocervical epithelium beyond the squamocolumnar junction gives the appearance of an ectopy. Relative risk of cervical cancer with COC use is 1.1. It may


be due to the persistent exposure of the pill users to HPV infection or due to their more sexual activity.
■   Uterus (OGN): Uterus may be slightly enlarged. Low-dose COCs do not usually increase the size of a pre-existing fibroid. COCs can reduce the amount of menstrual bleeding.
■   Vagina (PGN): Cytohormonal study reflects the picture of early luteal phase.
■   Other organs: (a) Liver: The liver functions are depressed; (b) Gastrointestinal Tract (GIT): There is increased incidence of mesenteric vein thrombosis; (c) Urinary: There is increased incidence of urinary tract infection but is probably related to increase in sexual activity.
Effects on Reproduction
■   Risk to fetus: When COC is taken during early pregnancy inadvertently there is no greater risk of significant congenital anomaly. Risk of congenital abnormality in general is 2-3%.
■   Lactation (OGN + PGN): Lactation is probably affected by a reduction in the milk production and also by alteration of the quality of the milk (reduction of protein and fat content). Moreover, significant amount of the steroids are ingested by the infant, the effects are as yet unknown. Mini-pill is a better alternative for the breastfeeders.
Types of Oral Contraceptive Formulations
In multiphasic preparation, minimum doses are provided for contraceptive effect in the early part of the cycle and slightly higher doses later in the cycle to prevent breakthrough bleeding. It is an attempt to minimize undesirable side effects of lipid metabolism.
1.  (a) Monophasic (fixed dose): Combined pills (COCs).
(b) Multiphasic (different dose combinations) with different tablet color): It may be biphasic, triphasic or four phasic.
The  theoretic advantage of phasic  preparations has little impact on clinical response.
2.  OC formulations and regimens: Most covers 28 days ( 4 weeks). Many combinations are-21 days (3 weeks) followed by 7 days hormone-free interval (HF!).
Most products contain spacer pills (iron) in the HF!. Bleeding usually occurs during the HFI (or 3-4 days). Some preparation contains active tablets for 24 days and HF! is 4 days. They are more effective than 21 days pill.
I CENTCHROMAN (SAHELI)
Female: Ormeloxifene is a research product of Central Drug Research Institute (CDRI) of Lucknow, India. It is a nonsteroidal compound with potent antiestrogenic and weak-estrogenic properties. !tis taken orally (30 mg) twice a week for first 3 months then once a week. It works primarily by preventing implantation of fertilized ovum. It creates asynchrony between developing zygote and the endometrium causing implantation failure. It does not inhibit ovulation.

Chapter 36: Population Dynamics and Control of Conception

Side effects are a few. It is avoided in polycystic ovarian disease, cervical cell hyperplasia, with liver (jaundice) and kidney diseases, and in tuberculosis. There may be a tendency of oligomenorrhea. The failure rate is about 1-4 per 100 women years of use. Failure rate is less with increased doses. It is devoid of any significant adverse metabolic and hormonal effect. This may also be used as safely by the lactating women and an emergency contraceptive. It is highly safe, effective and a reversible method.  It has no teratogenic effect and return of fertility is immediate. It is sold against prescription only and not over the counter.
Noncontraceptive use: Because of its potent antiestrogenic activity, centchroman is being currently tried in the management of DUB, endometrial hyperplasia, endometriosis and breast cancer. It is used as HRT, because of its weak estrogenic property.
However; risk of VTE is lower compared to pregnancy and puerperium.

SUMMARY OF CHC
(1) Women with weight >90 kg may have less efficacy of CHC; (2) Women with bariatic surgery may have less efficacy of CHC;
(3) Additional contraceptive is not required when non-enzyme induing drugs are used; (4) Users of CHC have slight absolute risk of VTE. Risk reduces after 1  year of use; (5) BP, BMI to be checked prior starting CHC. Pelvic/breast examination is not required; (6) Annual review is advised; (7) CHC is stopped 4 weeks before surgery; (8) Can be used till 50 years of age; (9) It is contraindicated in personal history of VTE, known thrombophilic, major surgery with prolonged immobilization
t
(MEC-4).

I PROGESTOGEN-ONLY CONTRACEPTIONS
Progestogen-only contraception includes: ■   Oral:POPs
11   Parenterals: DMPA, NET-EN, Implants (Implanon) ■   LNG-IUS.
Progestin-only Pill (POP/Minipill)
Progestin-only pill is devoid of any estrogen compound. It contains very low dose of a progestin in any one of the following forms-levonorgestrel 75 µg, norethisterone 350 µg, desogestrel 75  tg, lynestrenol 500  tg or norgestrel 30 µg. It has to be taken daily around same time each day from the first day of the cycle with no pill free interval. Mechanism of action:It works mainly by making cervical mucus thick and viscous, thereby prevents sperm penetration. Endometrium becomes atrophic, so blastocyst implantation is also hindered. This cervical effect is apparent by 2 days of startingPOP. But as it is short lived ( <24 hours),  daily prescription of POP is given. In about 2% of cases, ovulation is inhibited and 50% women ovulate normally.
How to prescribe a minipill?: Thefirst pill has to be taken on the first day of the cycle and then continuously. It has to be taken regularly and at the same time ofthe day. There must be no break between the packs. Delay in intake for more than 3 hours (i.e., >27 hours late; c.f DSG in next page), the woman should have the missed pill immediately and the next one as scheduled. Extra
precaution has to be taken for next 2 days.
Advantages: (a) Side effects attributed to estrogen in the combined pill are totally eliminated; (b) No adverse effect on lactation and hence can be suitably prescribed in lactating women and as such it
f
r
f

l -----ED Chapter 36: Population Dynamics and Control of Conception

is often called 'Lactation Pill'; (c) Easy to take as there is no'Onand Off' regime; (d) It may be prescribed in patient having (medical disorders) hypertension, fibroid, diabetes, epilepsy, smoking, and hist01y of thromboembolism, HIV positive women; (e) Reduces the risk of PID and endometrial cancer. Disadvantages:  (a) There may be acne, mastalgia, headache, breakthrough bleeding (Can be controlled by adding estrogen supplementation), or at times amenorrhea in about 20-30% cases; (b) All the side effects, attributed to progestins may be evident; (c) Simple cysts of the ovary may be seen, but they do not require any surge1y; (d) Ectopic pregnancy: 1 in 10; (e) Failure rate is about 0.3-2 per 100 women years of use. Failure is more in young compared to women over 40. Women using drugs that induce liver microsomal enzymes to alter metabolism should avoid this method of contraception.
Contraindications:  (a) Pregnancy; (b) Unexplained vaginal bleeding; (c) Recent breast cancer; (d)  Arterial disease; (e) Thromboembolic disease; (f) Women taking antiseizure drugs.

SUMMARY OF POP
(1) If used consistently and correctly, POP are >90% effective; (2) Desogestrel (DSG) Pills inhibit Ovulation in 97% of cycles (c.f. LNG) and have a 12-hour window for missed pills (i.e., 36 hours of missed pills) (c.f. LNG); (3) Return to fertility is immediate after stopping.

Injectable Progestins
The preparations commonly used are Depo Medroxy Progesterone Acetate (DMPA) and Norethisterone Enanthate (NET-EN). Both are administered intramuscularly (deltoid or gluteus muscle) within 5 days of the cycle. The injection should be deep, Z-tract technique and the site not to be massaged. DMPA in a dose of 150 mg every three months (WHO, 4 months) or 300 mg every six months;
NET-EN in a dose of 200 mg given at two monthly intervals.








Medroxyprogesteroneace­ tate (SAYAnA PRESS): Injection 104 mg/0.6S ml. It is available as a pre-filled single dose injec­ tor. The injector  needs  to  be activated by pushing the nee­ dle  shield firmly  towards  the port, before use. The medicine appears white and uniform. The suspension is to be shaken vig­ orously  just  before  use.  It  is given  by  SC  injection  into  the anterior   thigh   or   abdomen every 3 months (12-14 weeks). It is administered by a health­ care   professional   or   by   the woman herself.

Depo-SubQ provera 104 (Uniject) contains 104 mg of DMPA. It is given subcutaneously over the anterior thigh or abdomen at


every 90 days. It suppresses ovulation for 3 months as it is absorbed more slowly.
Mechanism of action: (a) Inhibition of ovulation-by suppressing the midcycle LH peak; (b) Cervical mucus becomes thick and viscid thereby prevents sperm penetration. As this effect takes approximately 7 days (c.f POP), additional contraception for 1st 7 days is required; (c) Endometrium is atrophic preventing blastocyst implantation.
Advantages: (a)  It eliminates regular medication as imposed by oral pill;  (b)  It can be used safely during lactation. It probably increases the milk secretion without altering its composition; (c) No estrogen-related side effects; (d) Menstrual symptoms, e.g.,  menorrhagia,  dysmenorrhea are reduced; (e) Protective against endometrial cancer; (f) Can be used as an interim contraception before vasectomy becomes effective; (g)  Reduction in PID, endometriosis, ectopic pregnancy and ovarian cancer. The noncontraceptive benefits are DMPA reduces the risk of-salpingitis, endometrial cancer; iron deficiency anemia, sickle cell problems, and endometriosis.
Disadvantages: Failure rate for DMPA-(0-0.3) (HWY). There is chance of irregular bleeding ( a COC can be used for 3 months) and occasional phase of amenorrhea. Return offertility fter their discontinuation is usually delayed for several months (6-12 months). However, with NET-EN the return of fertility is quicke,: Loss of bone mineral density (reversible) has been observed with Jong-term use of depot provera. It is suitable for adolescents and the perimenopausal women. However, most bone Jost is restored within 5 years of stoppage. Overweight, insulin-resistant women may develop diabetes. Other side effects are depression, weight gain, and headache.
Contraindications: Women with high-risk factors for osteo­ porosis, breast cancer, and the others are same as in POP.

SUMMARY OF INJECTABLE PROGESTINS
(1) Both DMPA and NET-EN are Long Acting PGN's. Amenorrhea is common and thus helpful for women with history of HMB; (2) It is a contraception of choice for women with Sickle Cell Disesase; (3) Weight gain is  a common complaint; (4) The injection of DMPA can be administered upto 4 months (i.e., 16 weeks); (5) The efficacy is not affected with concurrent use of enzyme inducing drugs.

Implant
Nexplanon is a progestin-only delivery system containing 3 ketodesogestrel (etonogestrel). It is a long-term (up to 3 years) reversible contraception (Fig. 36.11). It consists of a single closed capsule (made of ethylene vinyl acetate copolymer 40 mm x 2 mm) and contains 68 mg of Etonogestrel (ENG). It releases the hormone about 60 µg, gradually reduced to 30 µg per day over 3 years. Imp/anon does not cause decrease in bone mineral density.
Mechanism of action: It inhibits ovulation in 90% of the cycles for the first year. It has got its supplementary effect on endometrium (atrophy) and cervical mucus (thick) as well.
Insertion: The capsule is inserted subdermally, in the inner aspect of the nondominant arm, 6-8 cm above the elbow fold. It is inserted between biceps and triceps muscles. Preloaded sterile applicator is available. No incision is required. Removal is done by making a 2 mm incision at the tip of the implant and pushing the rod until it pops out. It is done under local anesthetic.
Chapter 36: Population Dynamics and Control of Conception	Jlt.







Fig. 36.11:  Single implant rod-implanon.


It is ideally inserted within D-5 of a menstrual cycle, immediately after abortion and 3 weeks after postpartum.
Removal: lmplanon should be removed within 3 years of insertion. Loss of contraceptive action is immediate.
Advantages  are  the  same as with DMPA. Others are­ (a) Highly effective for long-term use and rapidly reversible; (b) Suited for women who have completed their family but do not desire permanent sterilization; (c) Improvement of anemia; (d) Reduced seizure frequency in some women with epilepsy; (e) Reduced frequency of pain crises rises in women with sickle cell disease. Efficacy of Nexplanon is extremely high with Pearl indices of 0.01. This safe and effective method is considered as 'reversible sterilization'. Risks: Infection, nerve injmy, migration or incorrect placement. Drawbacks: frequent irregular menstrual bleeding, spotting and amenorrhea are common. Dificulty in removal is felt occasionally. Nexplanon can be imaged (X-ray, USG, MRI); if not palpable during removal. Contraindications are similar to POP.
Norplant-II (Jade/le)
Two rods of 4 cm long with diameter of 2.5 mm is used. Each rod contains 75 mg of levonorgestrel. It releases 50 µg of levonorgestrel per day. Contraceptive efficacy is similar to combined pills. Failure rate is 0.06 per 100 women years. It is used for 3 years. The rods are easier to insert and remove.
Long-Acting Reversible Contraception (LARC) needs only one time motivation for long-term use. There is no risk of user error once it is placed in the body. LARCs are highly effective and immediately reversible with rapid return offertility after its removal. Contraindications of LARCs are very few. It is recommended for the lactating women. It can be used in the postpartum or postabortal period. It has high continuation rate  and user satisfaction. It is offered as first line contraception (ACOG, 2009). The common LARC methods are: Copper-T 380A, LNG-IUS, Implants (Nexplanon).

SUMMARY OF IMPLANT
(1) No or little risk ofVTE, Stroke or Ml; (2) Infrequent bleeding is the main cause of menstrual symptoms. A COC may be advised to counter the menstrual issues during implant use. About 1 in 5 women have amenorrhea; (3) Enzyme inducing drugs affect the efficacy of implants during use and till 28 days after stopping. So additional contraception is advised.

EMERGENCY CONTRACEPTION (SYN: POSTCOITAL CONTRACEPTION)
■   Hormones	■   IUD
■   Antiprogesterone	■   Others
Indications of emergency contraception: Unprotected inter­ course, condom rupture, missed pill, delay in taking POP for more than 3 hours (12 hours with DSG POP), sexual assault or rape and


first time intercourse, as known to be always unplanned. In the days immediately prior to ovulation and on the day of ovulation itself, pregnancy risk following a single episode of Unprotected Sexual Intercourse (UPSI) has been estimated to be up 30%.

Indications
1.  After UPSI on any day of natural cycle.
2.  UPSI from D-21 after child birth (unless criteria for lacational amenorrhoea are met).
3.  UPSI from D-5 after abortion, miscarriage, ectopic pregnancy or uterine evacuation of GTD.
Methods: (1) Cu IUCD-(most effective); (2) Ulipristal acetate (UPA-EC-2nd most effective); (3) LNG (3rd most effective) (Table 36.5).
Cu IUCD: It is toxic to sperms and ova, inhibits fertilization and also prevents implantation. It is inserted within 5 days of first UPSI in a cycle. It has both pre- and post-fertilization inhibition. Pregnancy rate <0.1 %.
Copper IUD: It is the gold standard method to be offered to all women for EC.
Advantage: It can be kept in place for 10 years if desired as a regular method of contraception.
Ulipristal acetate as an EC is superior to levonorgestrel. It is a progesterone receptor modulator. A single dose 30 mg, to be taken orally as soon as possible or within 120 hours of coitus. It acts by suppressing follicular and endometrial growth. It delays ovulation and inhibits implantation. Overall pregnancy rate after UPA EC is 1-2%. It should neither be prescribed in women with severe hepatic dysfunction nor with severe asthma.
Levonorgestrel (E. pills) 0.75 mg, two doses given at 12 hours interval, is very successful and without any side effects. The two tablets (1.50 mg) can be taken as a single dose also (Fig. 36.12). The first dose should be taken within 72 hours (most effective) may be taken up to 120 hours. This drug is successful in 85% cases. However LNG cannot act once LH surge has happened.
No fetal adverse effect has been observed when there is failure of emergency contraception. However, induced abortion should be offered to the patient, if the method fails.
Mode of action: The exact mechanism of action remains unclear. The following are the possibilities:
■   Ovulation is either prevented or delayed when the drug is taken in the beginning of the cycle.
■   Fertilization is interfered.
■   Implantation is prevented (except E. pills) as the endome­ trium is rendered unfavorable.
■   Interferes with the function of corpus luteum or may cause luteolysis.
Drawbacks: Nausea and vomiting are much more intense with estrogen use. Antiemetic (meclizine) should be prescribed.
'---""-· -Ei Chapter 36: Population Dynamics and Control of Conception Table 36.5: Emergency contraceptives .

Method/
drug	Dose	Timing of use


Failure rate

Individual: Obese/Enzyme
inducing drugs(+)	Breast feeding	Contraindication



Cu IUCD    -

UPA	30mg


Up to 120hours of UPSI or within 5	<0.1% days of ovulation; whichever is later.
Up to 120hours of UPSI	1-2%


Ideal

Less effective


Uterine perforation
No breastfeeding upto 1 week


-

Asthma, glucocorticoid use



LNG	1.5 mg   Up to 72hours of UPSI (ineffective after 96hours of UPSI)


0.6-2.6% Double the dose (3mg)	Nil effect [Less effective)

Concurrent use of UPA and LNG to be avoided.





LEVONORGESTREL TABLETS 1.P.
ezy•pill
 
M•
An Oral Emergency Conlroceptive for Women
-ft
m'l"'a.-1il-
Fig. 36.12:  Levonorgestrel (LNG) pill.

Postcoital contraception is only employed  as an emergency measure and is not effective if used as a regular method of contraception.
Yuzpe method (combined hormonal regimen) is equally effective. Two tablets of ovral (0.25 mg levonorgestrel and 50 µg ethinyl estradiol) should be taken as early as possible after coitus (<72 hours) and two more tablets are to be taken 12 hours later.
Oral antiemetic (10 mg metoclopramide) may be taken 1 hour before each dose to reduce the problem of nausea and vomiting.

Anti progesterone
Antiprogesterone (RU 486-mifepristone) binds competitively to progesterone receptors and nullifies the effect of endogenous progesterone.
Dose: A single dose of 100 mg is to be taken within 5 days of intercourse. Implantation is prevented due to its antiprogesterone effect. Pregnancy rate is 0-0. 6%.

I SUMMARY OF ORAL CONTRACEPTIVES
■  Combined Hormonal Contraceptive (CHC) ■  Triphasic pill
■   Emergency (postcoital) contraception

■   Minipill
■  Conventional combined preparations:  The widely used oral contraceptives consist of tablets containing estrogen and progestin compounds. It is the most effective and reversible method of contraception. Each tablet usually contains 30 mg of ethinyl estradiol and 1 mg of norethisterone or 0.3 mg norgestrel. It has got trigger action-(a) inhibition of ovulation, (b) production of static endometrial hypoplasia, and (c) alteration of the character of the cervical mucus. Its use is absolutely contraindicated in cases with circulatory diseases,  liver diseases,  severe  migraine, and estrogen­ dependent tumor. The pill should be started from the day one of a cycle and continued as '3  weeks on and 1 week off' regime. Periodic check-up is essential, especially when prescribed in women above the age of 35. The pill should be withdrawn if complications arise such as severe migraine, chest pain, visual disturbances, etc.
The   beneficial   effects   are   relief   of  dysmenorrhea, premenstrual tension, endometriosis, acne, hirsutism, and lesser chance of ectopic and PID. It gives protection against ovarian and endometrial carcinomas.
The minor side effects are nausea, vomiting, breakthrough bleeding, mastalgia, leg cramp, weight gain, hypomenorrhea or  amenorrhea.  The  major  complications  are  rare  and include  depression,  hypertension  and  thromboembolic manifestations. The failure rate is about 0.1 per HWY.
11  Triphasic pill: It has got lesser amount of steroids than the conventional monophasic tablets. There is lesser effect on lipid metabolism.
■   Emergency: Following unprotected or accidental exposure any of these methods can be used: (1) CU IUCD is most effective. (2) UPA second most effective. (3) LNG is third most effective (Table 36.5).
11  Minipill: The pill contains low doses of progestin-norgestrel 30 mg, levonorgestrel 75 µg or desogestrel 75 µg. It should be taken daily and can be safely prescribed during lactation. It is best suited where estrogen is contraindicated.




►   Medical eligibility criteria (WHO) for the use of any method of contraception is categorized as: ( 1) No restriction for use of the method; (2) Advantages of using the method generally outweigh the theoretical or proven risks, (3) Theoretical or proven risks usually outweigh the advantages of using the method, (4) Health risks are unacceptable if the contraceptive method is used.
►  Combined Oral Contraceptives (COCs) are very reliable apart from their many other health benefits.
►   Mechanism of action of COCs are: (a) Inhibition of ovulation by suppression of FSH and LH, (bl Making endometrium nonreceptive for implantation (endometrial hypoplasia), (c) Making cervical mucus thick, viscid and scanty, and (d) Probably alters tubal motility.
►   Absolute contraindications of oral pills, major side effects and indications of withdrawal of pills have been discussed.
Contd...
Chapter 36: Population Dynamics and Control of Conception

Contd...
►  The newer low-dose pills with more specific and 'lipid friendly' progestins reduce the health risk further.
►  Drospirenone containing COC is useful in treating PMS, PMDD. It should not be used in women with renal, adrenal or hepatic dysfunction.
►  A woman who does not smoke and has no other risk factor for cardiovascular disease, may continue the pill (with careful monitoring) until the age of 50.
►  Combined oral contraceptives: (a) Contain estrogen and progestin compounds; (b) Third-generation progesterone may increase the risk of VTE; (c) Current users of COCs have an increased risk of breast cancer (RR 1.24); (d) With perfect use, failure rate is 0.1 per 100 WY; (e) It is contraindicated in women with arterial or venous disease.
►  Progestogen-only contraceptions
(a) Does not inhibit ovulation completely; (b) Irregular vaginal bleeding is often associated and it may be the reason for discontinuation; (c) LNG-IUS may cause amenorrhea due to endometrial atrophy. DMPA should be used in adolescents and perimenopausal women after consideration of other methods. Importantly, most bone mass loss during DMPA use is restored within 5 years after its discontinuation; (d) DMPA does not increase the risk of cardiovascular disease but is associated with decreased BMD.
►  Low-dose progestin pill (minipill) is advantageous in lactating women, as it has got no adverse effect on breast milk. It can be used as a suitable alternative where estrogen is contraindicated.
►  Overall safety of DMPA is clearly greater than COC. Norplant and implanon are safe and effective for long-term use. Both are considered as 'reversible sterilization'.
►  Long acting reversible contraceptives ((arcs) include: LNG-IUS, CU IUD, progesterone only injectables and implant. Pregnancy rates are extremely low with LARCs. These are user independent methods. The women need to do nothing until the method has expired.
►  Emergency contraception includes hormones, IUD and antiprogesterone (RU 486). Within 72 hours, hormonal preparations are effective; within 5 days, IUD is effective and Ru 486 should be taken within day 27 of cycle irrespective of the day and number of intercourse.
►  Centchroman in a nonsteroidal antiestrogenic compound used as once a week contraceptive pill. It acts by preventing the implantation of the fertilized ovum. It has many benefits.



DRUG INTERACTION WITH HORMONAL CONTRACEPTION

Pharmacokinetic of drug interactions: It is observed when one drug alters the absorption, distribution, metabolism or excretion of another drug, and changes its bioavailability. The pharmacokinetic interactions of a drug that induces hepatic cytochrome P 450 enzymes, increase the clearance of contraceptive hormones. This results in reduced contraceptive effectiveness of many hormonal contraceptives. These are: all Combined Hormonal Contraceptives (CHC),  all POPs, etonogestrel implant and oral emergency contraceptions. (Importantly, contraceptive effectiveness of the progestogen-only injection, locally acting levonorgesterel releasing intrauterine systems and the copper IUDs are not apparently affected by the enzyme inducing drug). On the other hand, pharmacokinetic interactions that inhibit cytochrome P450 could result in increased exposure of  contraceptive hormones. There is  potentially increased risks and side effects. Risk of thrombosis is increased in the case of elevated serum levels of ethinylestradiol. CHC induce glucuronidation of lamotrigine and reduces lamotrigine exposures. This reduces the seizure control.
Other Clinical Scenarios
■  Unless the antibiotic is an enzyme inducer or it causes vomiting or diarrhea, no additional contraceptive precaution is needed.
■  Combined Hormonal Contraceptives (CHC):  Combined pill, patch or vaginal ring-effectiveness could be reduced with the use of enzyme inducing drug. Alternative effective method is to be used.
■   DMPA: No effect on contraceptive effectiveness. No need of extra precaution.
■  LNG-IUS: No effect on contraceptive effectiveness. No need of extra precaution.

■  CU-IUD: No effect on contraceptive effectiveness. It is most effective as emergency contraception.
■   LNG-EC: Effectiveness could be reduced. Cu-IUD is most effective.
■  UPA-EC: Effectiveness could be reduced. Cu-IUD is most effective.
■   IMP, DMPA, LNG-IUS, Cu-IUD: In the event of vomiting or diarrhea. No need of additional precaution.

STERILIZATION
Permanent method of contraception is done either for the male or female. Sterilization is a highly effective and safe method. In contrast to other methods, which are reversible or temporary, sterilization should be considered permanent. If a women who have tubal sterilization, wish to conceive, IVF can be used otherwise tubal reconstructive surgery is the alternative. For the male, anastomosis of vas deferens could be done. The operation done on male is vasectomy and that on the female is tubal occlusion, or tubectomy.

I PRESTERILIZATION COUNSELING

It includes a discussion of the following issues: (a) Desire of the individual partner (male/female); (b) Procedure selection; (c) Failure rate; (d) Risks and side effects; (e) Issue ofreversibility. Reversal is more likely to be successful after laparoscopic clips compared to laparotomy procedures. However, the risks of ectopic pregnancy is there; and (f) Options for alternative long active (equally effective) reversible methods (Implants, Cu-T 380A) should be given.
Pre sterilization Information and advice:
■  This covers both verbal and written information. II  It is done with both the partners together.
ED Chapter 36: Population Dynamics and Control of Conception

■   Include information with other methods including LARCs. ■  Includes information about failure rate and complications.

Surgery
Advantages of vasectomy over tubectomy: (a) Can be done in the clinic under local anesthesia; (b) No entry to peritoneal cavity; (c) Less time needed (20 minutes); (d) Complications are less; (e) No hospital admission or stay; (f)  Highly effective; (g) Minimum side effects; (h) Low cost; and (i) Simple to perform.

I MALE STERILIZATION Vasectomy (Fig. 36.13)
It is a permanent sterilization operation done in the male where a segment of vas deferens of both the sides are resected and the cut ends are ligated.
Advantages: (a) The operative technique is simple and can be performed by one with minimal training; (b) The operation can be done as an outdoor procedure or in a mass camp even in remote villages; (c) Complications-immediate or late are fewer;  (d) Failure rate is minimal-0.15% and there is a fair chance of success of reversal anastomosis operation (70-80%); ( e) The overall cost is minimal in terms of equipment, hospital stay and doctor's training.
Drawbacks: (a) Additional contraceptive protection is needed for about 2-3 months following operations, i.e., till the semen becomes free of sperm; (b) Frigidity or impotency when occurs is mostly psychological.
Selection of candidates: Sexually active and psychologically adjusted husband having the desired number of children is an ideal one.

No-scalpel Vasectomy
No-Scalpel Vasectomy (NSV) is commonly done at present in India. It was popularized by Dr Li Shun Qiang of China in 1991.
Technique
Written consent of the person is taken following counseling. The operation is done as an outdoor procedure or in the camp. The local area is shaved and cleaned with povidone-iodine lotion. Full surgical asepsis has to be maintained during operation. Procedure is done under local anesthetic.


The vasa is palpated with three fingers of the left hand; index and thumb in front and the middle behind. This is done at the level midway between the top of the testis and the base of the penis. The vasa is grasped with a ringed clump applied perpendicularly on the skin overlying the vasa. The skin is punctured with the sharp pointed end of the medial blade of dissecting forceps. The puncture point is enlarged by spreading the tissues (dartos muscle and spermatic fascia) inserting both the tips of the dissecting forceps. The vasa is elevated with the dissecting forceps and in hold with the ringed clamp. At least 1 cm of length ofvasa is made free and mobilized. The vasa is ligated at two places 1 cm apart by No. '00' chromic catgut and the segment of the vasa in between the ligatures is resected out. Division of the vasa should be accompanied by fascia! interposition or diathermy. This reduces the failure rate. Hemostasis is secured. No skin suturing is needed. Wound dressing is done and a small pressure bandage is applied. The same procedure is repeated on the other side. A scrotal suspensory bandage is worn. The patient is allowed to go home after half an hour. Histological examination of the excised segment of the vasa should be done for confirmation if the surgeon is in any doubt.
Advices
Antibiotic (injection penidure LA 6 IM) is administered as a routine and an analgesic is prescribed. Heavy work or cycling is restricted for about 2 weeks, while usual activities can be resumed forthwith. For check-up, the patient should report back after 1 week, or earlier, if complication arises. Additional contraceptive should be used for 3-4 months.
NSV takes less time, helps faster recovery due to less tissue injury. Complications are significantly less. However, it needs training on the part of the surgeon.
Precaution
The man does not become sterile soon after the operation as the semen is stored in the distal part of the vasa channels for a varying period of about 3 months. It requires about 20 ejaculations to empty the stored semen. Semen should be examined either by one test after 16 weeks or by two tests at 12 and 16 weeks after vasectomy and if the two consecutive semen analyses show absence of spermatozoa, the man is declared as sterile. Till then, additional contraceptive (condom or DMPA to wife) should be advised.




'\_	olding the vas with the
._
\t',, , '
ringed clamp at 90° t:
'	 

.
Local anesthetic infiltration	,

Complications
Complications of NSV are significantly less.
■   Immediate:  (a)  Wound  sepsis  which may lead to scrotal cellulitis or abscess; (b) Scrotal hematoma.
■  Remote: (a) Frigidity or impotency: It is mostly psychological in origin; (b) Sperm granuloma is due to inflammatory reaction to sperm leakage. This can be prevented by cauterization or fulguration of the cut ends; (c) Chronic intrascrotal pain and discomfort (post-vasectomy syndrome) may be due to scar tissue formation, or tubular distension of the epididymis; (d) There is no increase in testicular cancer or heart disease. Risk of prostate cancer is considered to have no causal association; (e) Spontaneous recanalization (1 in 2,000) is rare.




-Inserting both    1	-Dissecting
the tips of the	.,	forceps is
dissecting forceps·--;_---  opened to strip

to dissect tissues	the sheath
Fig. 36.13:  Method of No-Scalpel Vasectomy (NSV) operation.

Other Methods to Block the Vasa
■  Electrocoagulation may be used to encourage scar tissue formation.
■  Fascia! interposition following ligation, excision, and cautery. This is done to prevent recanalization.

I FEMALE STERILIZATION
Occlusion of the fallopian tubes in some form is the underlying principle to achieve female sterilization. It is the most popular method of terminal contraception all over the world.
Indications
1.  Family planning purposes: This is the principal indication in most of the developing countries.
2.  Socioeconomic:  An individual is adopted to accept the method after having the desired number of children.
3.  Medicosurgical   indications   (female   partner):   (a) Medical diseases such as heart disease, diabetes, chronic renal  disease,  hypertension  are  likely  to  worsen,  if repeated pregnancies occur; (b) During third time repeat cesarean section or following repair of prolapse to avoid complications.
4.  Risk-reducing salpingectomy: As a preventive measure against serous ovarian and peritoneal cancer.
Time of Operation
1.  During puerperium {puerperal): If the patient is otherwise healthy, the operation can be done 24-48 hours following delivery. Its chief advantage is technical simplicity. Hospital stay and rest at home following delivery are enough to help the patient to recover simultaneously from the two events, i.e., delivery and operation.
2.  Interval: The operation is done beyond 3 months following delivery or abortion. The ideal time of operation is following the menstrual period in the proliferative phase.
3.  Concurrent  with  Medical  Termination  of Pregnancy {MTP) and at the time of cesarean section: Sterilization is performed along with termination of pregnancy. This is mostly done, especially in the urban centers.
4.  Concurrent with cesarean delivery with prior consent.
Methods of Female Sterilization
Occlusion by resection of a segment of both the fallopian tubes (commonly called tubectomy) is the widely accepted procedure. Currently, occlusion of the tubes with rings or clips or electrocoagulation using a laparoscope is gaining popularity. Hysterectomy during the childbearing period has got an incidental sterilization effect but should not be done for sterilization purpose.
Tubectomy
It is an operation where resection of a segment of both the fallopian tubes is done to achieve permanent sterilization. The approach maybe:
■   Abdominal	II  Vaginal
Abdominal
11   Conventional	11  Minilaparotomy

Conventional (Laparotomy)
Steps
II   Anesthesia:  The operation can be done under general or spinal or local anesthesia. In mass camp, local anesthesia is preferable.  In case of local anesthesia,  premedication with injection  morphine  15 mg or injection pethidine 100 mg with phenergan 50 mg IM is to be administered at

Chapter 36: Population Dynamics and Control of Conception

least 30-45 minutes prior to surgery. The incisional area is infiltrated with 1 % lignocaine.
II   Incision: In puerperal cases, where the uterus is felt per abdomen, the incision is made two fingers breadth (l") below the fundal height and in interval cases, the incision is made 2 fingers' breadth above the symphysis pubis. The incision may be either midline or paramedian or transverse. The abdomen is opened by the usual procedure.
II  Delivery of the tube: The index finger is introduced through the incision. The finger is passed across the posterior surface of the uterus and then to the posterior leaf of the broad ligament from where the tube is hooked out. The tube is identified by the fimbrial end and mesosalpinx containing utero-ovarian anastomotic vessels.

Techniques (Figs. 36.14A to F)
11  Pomeroy's: A loop is made by holding the tube by an Allis forceps in such a way that the major part of the loop consists mainly of isthmus and part of the ampullary part of the tube (at the junction of proximal and middle third). Through an avascular area in the mesosalpinx, a needle threaded with No. 'O' chromic catgut is passed and both the limbs of the loop are firmly tied together. About 1-1.5 cm of the segment of the loop distal to the ligature is excised. The tube is so excised as to leave behind about 1.5 cm of intact tube adjacent to uterus. Segment of the loop removed is to be inspected to be sure that the wall has not been partially resected and to send it for histology. The same procedure is repeated on the other side. Because of the absorption of the absorbable ligature, the cut ends become independently sealed off and are separated after  a few  weeks. Advantages:  It  is easy,  safe,  and  very effective in spite of the simplicity of the technique. The failure rate is 0.1-0.5%. The cut ends become independently sealed off and retract widely from each other {Fig. 30.14C).
11   Uchida technique: A saline solution is injected subserosally in the midportion of the tube to create a bleb. The serous coat is incised along the antimesenteric border to expose the muscular tube. The tube is ligated with No.  'O' chromic catgut on either side and about 3-5 cm of the tube is resected offThe ligated proximal stump is allowed to retract beneath the serous coat. The serous coat is closed with a fine suture in such a way that the proximal stump is buried but the distal stump is open to the peritoneal cavity. No failure in this method has been observed so fa,:
II   Irving  method:  The  tube  is  ligated  on  either  side  and midportion of the tube (between the ties) is excised. The free medial end of the tube is then turned back and buried into the posterior uterine wall creating a myometrial tunnel {Fig. 36.14D).
II  Madlener technique (Fig. 36.l4E): It is the easiest method. The loop of the tube is crushed with an artery forceps. The crushed area is tied with black silk. The loop is not excised. The failure rate is very high to the extent of 7% and hence, it is abandoned in preference to the Pomeroy's technique.
II   Kroener  method  of  fimbriectomy  is  not  a  common procedure (Fig. 36.l4F).
The abdomen is closed in layers. Antibiotics are given routinely in the postoperative period. The abdominal stitches are removed on the 5th day and the patient is discharged. However, if the patient has satisfactory postoperative progress, she may be discharged after 48 hours. The stitches may be removed in the outpatient department.
Ii Chapter 36: Population Dynamics and Control of Conception






















Figs. 36.14A to F:  Steps of tubectomy by Pomeroy's method: (A) A segment of the fallopian tube is lifted up; (B) The loop is ligated with chromic catgut and is cut (about 1 .5 cm); (C)  End result of the operation-note wide separation; (D)  Irving procedure: The medial cut end is buried in the myometrium posteriorly and the distal cut end is buried in the mesosalpinx; (E) Madlener procedure; (F) Kroener procedure: The ampullary end of the tube is ligated and resected.


Minilaparotomy (Mini-Lap)
When the tubectomy is done through a small abdominal incision along with some device, the procedure is called mini-Lap. It has been popularized by Uchida of Japan ever since 1961.

Steps
(1) Anesthesia: Always under local anesthesia: (2) Plan of incision: As described in conventional method but the incision should be 1/2" - 3/4"; (3) Especially designed retractor may be introduced after the abdomen is opened; ( 4) Uterus is elevated or pushed to one side or the other by the elevator that has already been introduced transvaginally into the uterine cavity. This helps manipulation of the tube in bringing it close to the incisional area, when it is seized by artery forceps; (5) The appropriate technique oftubectomyis performed on one side and then repeated on the other side; (6) The peritoneum is closed by purse string suture. Once conversant with the technique, it can be performed with satisfaction to the patient. It also benefits the organization (turnover of the patient per bed is more than that in the conventional
method). The patient is usually discharged within 24-48 hours.
Vaginal ligation: Tubectomy through the vaginal route may be done along with vaginal plastic operation or in isolation. When done in isolation, the approach to the tube is through posterior colpotomy. Surgeon needs additional skill of vaginal surgery. Interval cases (uterus <12 weeks) are most suited. It is done under general or spinal anesthesia. It takes longer time. Laparotomy may sometimes be needed due to difficulties.
Complications: Hemorrhage, broad ligament hematoma, and rarely rectal injury. Dyspareunia may be a late complication
Advantage: Short hospital stay is convenient in obese women. Its limitation and relative merits and demerits are given in Table36.6.


Laparoscopic Sterilization
Laparoscopy is the commonly employed method of endoscopic sterilization (Fig.36.15). It is gradually becoming more popular­ especially, in the camps (Fig.36.16). The procedure is mostly done under local anesthesia. The operation is done in the interval period, concurrent with vaginal termination of pregnancy or 6 weeks following delivery. It should not be done within 6 weeks of delivery.
The procedure can be done either with single or double puncture technique. The tubes are occluded either by a silastic ring (silicone rubber with 5% barium sulfate) devised by Fallope or by Filshie clip is made of titanium lined with silicone rubber. Only 4 mm of the tube is destroyed. Failure rate is 0.1 %. Hulka­ Clemens spring clip is also used. Electrosurgical methods: Desicates the tissue by heating. Unipolar or bipolar method of tubal coagulation is used. Bipolar cautery is safer than unipolar one but it has higherfailure rates (2.1 %}. Laser photocoagulation is not popular because of high recanalization rate.
Principal Steps (Single Puncture Technique)
Premedication: Pethidine hydrochloride 75-100 mg with phenergan 25 mg and atropine sulfate 0.65 mg are given intramuscularly about half an hour prior to operation.
Local anesthesia: Taking usual aseptic precautions about 10 mL of 1 % lignocaine hydrochloride is to be infiltrated at the puncture site (just below the umbilicus) down up to the peritoneum.
Position of the patient: The patient is placed in lithotomy position. The operating table is tilted to approximately <15° of Trendelenburg position. Usual aseptic precaution is taken as in abdominal and vaginal operations. The bladder should be fully emptied by a metal catheter. Pelvic examination is
Chapter 36: Population Dynamics and Control of Conception

Table 36.6:  Mini-Lap vis-a-vis laparoscopic sterilization.
Features	Mini-Lap	Laparoscopic sterilization	,

Principle
Personnel


Resection of portion of the tube.
Any medical personnel with surgical skill.

Using biopolar cautery sialistic band (Fallopering) or Filshle clip.
Should only be performed by persons with special training.

Selection of time   Any time-puerperium, interval (with MTP).	Should not be done within 6 weeks of delivery or with enlarged uterus.

Contraindication

Complication life-threatening
Hospital stay Failure rate
Reversibility


Practically none. Can be done in conditions contraindicated for laparoscopy.
Minimal but usually not.

3-4 days (long stay). 0.1-0.3%.
Difficult due to adhesions and reduced remnant tubal length.

Lung lesions, organic heart diseases, intra-abdominal adhesions, extreme obesity.
Minimal but at times fatal.

3-4 hours (short stay). 0.2-0.6%.
Easier and effective. Only 4 mm of the tube is destroyed with the Filshie clip.

(MTP: Medical Termination of Pregnancy)













Fig. 36.15:  Laparoscopic tubal sterilization by Filshie clip. Filshie (GM Filshie) clip is made of titanium and the inner surfaces are lined with silicone. It is easier to apply and damage to the tube is less.
















Fig. 36.16: Laparoscopic instruments for tubal sterilization.

done methodically. A uterine manipulator is introduced through the cervical canal for manipulation for visualization of tubes and uterus at a later step.
Producing pneumoperitoneum: A small skin incision (1.25 cm) is made just below the umbilicus. The Veress needle is introduced through the incision with 45°  angulation into the peritoneal cavity. The abdomen is inflated with about 2 liters of gas (carbon dioxide or nitrous oxide or room air or oxygen). Choice of gas depends upon the method of sterilization.

Introduction of the trocar and laparoscope with ring-loaed applicator: Two silastic rings are loaded one after the other on the applicator with the help of a loader and pusher. The tr9car with cannula is introduced through the incision previously made with a twisting movement. The trocar is removed and the laparoscope together with ring applicator is inserted through the cannula (Fig. 36.15).
The ring loaded applicator approaches one side of the tube and grasps at the junction of the proximal and middle third of the tube. A loop of the tube (2.5 cm) is lifted up, drawn into the cylinder of the applicator and the ring is slipped into the base of the loop under direct vision. The procedure is to be repeated on the other side (Fig. 36.15).
Removal of the laparoscope: After viewing that the rings are properly placed in position, the tubal loops looking white and there is no intraperitoneal bleeding, the laparoscope is removed. The gas or air is deflated from the abdominal cavity. The abdominal wound is sutured by a single chromic catgut suture.
Risk reducing salpingectomy: Bilateral total salpingectomy is recommended as it reduces the risk of ovarian cancer (endometrioid and serous types) up to 34 % (SGO, 2013). This is especially beneficial for high-risk women (BRCA 1 or BRCA 2 mutation).
Comments on Methods of Female Sterilization
In the LMIC, mini-lap remains the mainstay in the National Family Planning Programme (NFPP) as a method of permanent sterilization. It is safe, has wider applicability, is less expensive and has got a less failure rate compared to laparoscopic sterilization. However, for a quick turnover in an organized mass camp, laparoscopic sterilization offers a promising success (Table 36.7).
Hazards of Tubal Sterilization
Immediate: These are related to general anesthesia and to the particular method used in sterilization. The related complications have already been discussed (Tables 36.6 and 36. 7).
Remote: (a) Specific for the approach; (b) Related to the sterilization.
ll   The remote complications specific for the approach of the operation, abdominal or vaginal have already been described.
II   The complications related to sterilization can be grouped into: (a)  General  complications:  These  include  occasional obesity, psychological upset; (b) Gynecological: (i) Chronic pelvic pain, (ii)
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-Ei Chapter 36: Population Dynamics and Control of Conception Table 36.7: Female sterilization.
Abdominal approach	Vaginal approach



Surgeon

Time of operation

Contraindication Anesthesia
Complication during operation
Duration of operation
Complications: Immediate Late
Hospital stay


Can be performed by any one conversant with surgery.
Can be done at any time, puerperal or interval.
Practically-nil, uterus <12 weeks size. Can be done under local anesthesia. Easy to tackle.

Shorter time.
Few
Wound infection, peritonitis-rare. lncisional hernia, failure rate-less.
Longer-5-6 days.
Shorter with mini-lap (24-48 hours).

Can be done only by a surgeon conversant with vaginal plastic operation.

Interval period is most suited. May be done in other times, provided the uterus is smaller than 12 weeks.
Associated to mass, uterus-> 12 weeks. General or spinal anesthesia is usually needed.
Difficult at times and laparotomy may be necessary.

Longer time.
Few
Hemorrhage, revealed or broad ligament hematoma, injury to the rectum. Dyspareunia, failure rate-more.
Shorter-24-48 hours.



Congestive dysmenorrhea, (iii) Menstrual abnormalities in the form of menorrhagia, hypomenorrhea or irregular periods. Pelvic pain, menorrhagia along with cystic ovaries constitute a post-ligation syndrome. It may be vascular in origin. However, the incidence can be minimized, if the blood vessels adjacent to the mesosalpinx are not unduly disturbed; (iv) Alteration in libido.
Failure Rate
The overall failure rate in tubal sterilization is about 0. 7%, the Pomeroy's technique being the lowest 0.1-0.5%, in contrast to the Madlener's, being 1.5-7%. The failure rate is increased when it is done during hysterotomy or during cesarean section. Failure rates of laparoscopic sterilization depend upon the individual method (electrocoagulation-unipolar 0. 75%, bipolar 2.1 %, Fa/lope ring 1. 7%, Filshie clip 0.1 %}. Failure may be due to fistula formation
or due to spontaneous reanastomosis.


Mortality following tubal sterilization is estimated to be 72 per 100,000 for all methods. Laparoscopic procedures carried the mortality rate of 5-10 per 100,000 compared to 7 per 100,000 for puerperal ligations.

Reversibility
Informed consent must be obtained after adequate counseling. Couple must understand the permanency of the procedure, its  occasional failure  rate,  the  risks and side  effects,  and its  alternatives.  Unfortunately,  regret  is  not  uncommon. Microsurgical  techniques  give  excellent  result  for  tubal reanastomosis.  Pregnancy rates after reversal are high (80%) following use of clips and  rings.  Reversal  of vasectomy with restoration of vasa patency is possible up to 90% of cases. But pregnancy rate is low (50%}.




►  Sterilization is the permanent method of surgical contraception. In male, it is vasectomy and that in female, it is tubectomy. ►  No Scalpel Vasectomy (NSV) is commonly done in India.
►  Tubectomy could be done by abdominal (common) or by vaginal route. Abdominally, it is done by conventional laparotomy or by minilaparotomy procedure. Pomeroy's method is commonly done.
►  A man is not sterilized immediately after vasectomy. As such, additional condom should be advised for at least 3 months.
►   No Scalpel Vasectomy (NSV) is done under local anesthetic making a tiny puncture over the stretched skin of the vasa. It has fewer complications. Both the NSV and scalpel vasectomy (SV) are safe.
►   Globally, tubal sterilization is the most common method (20%) of contraception followed by IUDs (15%), oral contraceptives (8%) and condoms (5%).
►  Counseling for sterilization should be done with all information.
►  Female sterilization operation can be done during puerperium (puerperal), in interval period or concurrent with MTP or cesarean delivery. Hysteroscopic methods of sterilization include insertion of quinacrine pellet and essure (microcoil).
►  Reversal of sterilization is not always successful. This should be counseled to the couple before sterilization operation. ►   Apart from conventional or mini-lap abdominal method, laparoscopic sterilization is very popular and effective.
►   Contraceptive prescription should be on an individual basis. In an individual, the method may vary according to her phase of reproductive life. Teenage girls, older women and sex workers should also be protected.


BARRIER METHODS
These methods prevent sperm deposition in the vagina or prevent sperm penetration through the cervical canal. The objective is achieved by mechanical barriers and by chemical means which produce sperm immobilization, or by combined means. The following are used.

TYPES OF BARRIER METHODS

11   Mechanical Male: Condom
Female: Condom, diaphragm, cervical cap ■   Chemical (vaginal contraceptives)
Creams: Delfen (nonoxynol-9, 12.5%)
Chapter 36: Population Dynamics and Control of Conception     Ba\-·

Foam tablets: Aerosol foams, Sponge (today) ll   Combination
Combined use of mechanical and chemical methods

I CONDOM (MALE)

Condoms  are made of polyurethane (lamb skin)  or latex. Polyurethane condoms are thinner and suitable to those who are sensitive to latex rubber. It is the most widely practiced method used by the male. In India, one particular brand (latex) is widely marketed as 'Nirodh'. The eficacy of condoms can be augmented by improving the quality of the products and by adding spermicidal agents during its use. Protection against Sexually Transmitted Disease  (STD)  is  an  additional  advantage.  Occasionally,  the partner may be allergic to latex. It should neither be too tight or too loose. A reservoir should be left at the tip to retain the ejaculate. Adequate lubrication should be used. Women who are at high risk of HIV infection, should not use monoxynol-9 spermicides as thus may increase the risk of HIV transmission.
The method is suitable for couples who want to space their families and who have contraindications to the  use of oral contraceptive or IUD. These are also suitable to those who have infrequent sexual intercourse.

I FEMALE CONDOM (FEMIDOM) (FIG. 36.17A)

It is a sheath made of polyurethane which lines the vagina and also the external genitalia. It is 17 cm in length with one flexible

polyurethane ring at each end. Inner ring at the closed end is smaller compared to the outer ring. Inner ring is inserted at the apex of the vagina and the outer ring remains outside. It gives protection against ST!s Cytomegalovirus (CMV} [HIV, Hepatitis B Virus (HBV)} and pelvic injlammato,y disease. It is expensive. Multiple uses can be made with washing, drying,  and with lubrication. Failure rate is about 5-21/HWY.

Use of Condom
(a) As an elective contraceptive method;  (b) As an interim form of contraception during pill use, following vasectomy operation (see later) and if an IUD is thought lost until a new IUD can be fitted; (c) During the treatment of trichomonal vaginitis of the wife, the husband should use it during the course of treatment irrespective of contraceptive practice; (d) Immunological infertility-male partner to use for 3 months. For other noncontraceptive benefits (Table 36.8).

I DIAPHRAGM (TABLE 36.9 AND FIG. 36.17B)
It is an intravaginal device made of a silicone cup with flexible metal or spring ring at the margin. Its diameter varies from 5 cm to 10 cm. It requires a medical or paramedical personnel to measure the size of the device. The largest size should be used without any discomfort or undue pressure. Caya (FDA approved) is a single dose diaphragm that does not require fitting by a medical person. Failure rate: Typical use 13-17%; perfect use 4-8%. Diaphragm and cervical cap may also reduce the risk of













Figs. 36.17A to C:  (A) Female condom; (8) Commonly used conventional contraceptive (diaphragm); (C)  Vaginal contraceptive (nonoxynol-9,  12.5%).


Table 36.8: Condom.	·
Advantages


.	,  , . _.,	,    · •	, ·	,	. Disadvantages



•  Cheaper with no contraindications. •   No side effects.
•   Easy to carry, simple to use and disposable.
•  Protection against sexually transmitted diseases, e.g., gonorrhea, Chlamydia, HPV and HIV.
•  Protection against pelvic inflammatory diseases. •   Reduces the incidence of tubal infertility and
ectopic pregnancy.
•  Protection against cervical cell abnormalities. •   Useful where the coital act is infrequent and
irregular.

•  May accidentally break or slip off during coitus. •  Inadequate sexual pleasure.
•  Allergic reaction (Latex).
•  To discard after one coital act.
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Precautions: (a) To use a fresh condom for every act of coitus. (b) To cover the penis with condom prior to genital contact. (c) Create a reservoir at the tip. (d) To withdraw while the penis is still erect. (e) To grasp the base of the condom during withdrawal.
=--'mJ    Chapter 36: Population Dynamics and Control of Conception

Table 36.9: Diaphragm.

Advantages
•  Cheap.
•  Can be used repeatedly for a long time. •  Reduces PID/STls to some extent.
•  Protects against cervical precancer and cancer.


Disadvantages
•  Diaphragm now come in two sizes, nulliparous and parous. There is no need of pelvic examination for fitting.
•  Risk of vaginal irritation, abrasion and urinary tract infection are there.
•  Not suitable for women with uterine prolapse.

Failure rate-16 (HWY).  (PIO: Pelvic Inflammatory Disease; STls: Sexually Transmitted Diseases)


cervical cancer. It should completely cover the cervix. As it cannot effectively prevent ascent of the sperms alongside the margin of the device, additional chemical spermicidal agent should be placed on the superior surface of the device during insertion, so that it remains in contact with the cervix.  The device is introduced up to 3 hours before intercourse and is to be kept for at least 8 hours after the last coital act. Ill-fitting and accidental displacement during intercourse increase the failure rate.
I VAGINAL CONTRACEPTIVES (FIG. 36.17C) Spermicides
Spermicides are available as vaginal foams, gels, creams, tablets, and suppositories.  Usually,  they  contain  surfactants like nonoxynol-9, octoxynol or benzalkonium chloride. The cream or jelly is  introduced  high in  the vagina  with the help of the  applicator  soon before coitus.  The duration of maximum effectiveness is usually not more than one hour. Foam tablets (1-2) are to be introduced high in the vagina at least 5  minutes  prior  to  intercourse.  In isolation,  it is not effective (18-29 HWY), but enhances the efficacy of condom or diaphragm when used along with it. There may be occasional local  allergic  manifestations  either  in  the  vagina  or  vulva.
Spermicide-microbicide combination supports the natural defense maintaining the acidic pH and acts as antimicrobial also. They are controlled by the female. These agents are protective against STis including HIV. The agents containing surfactant, destroy the sperm membrane and also the outer envelops of the virus and bacteria.

Vaginal Contraceptive Sponge (Today)
It is made of polyurethane impregnated with 1 g of nonoxynol-9 as a spermicide. Nonoxynol-9 acts as a surfactant which either immobilizes or kills sperm. It releases spermicide during coitus, absorbs ejaculate and blocks the entrance to the cervical canal. The sponge should not be removed for 6 hours after intercourse. Its failure rate (WY) is about-parous women: 32-20, nulliparous 16-9. Moreover, it produces lesions in the genital tract when used frequently. Those lesions are associated with increased risk of HIV transmission. Sponge should not be used during mens or puerperium.

I FERTILITY AWARENESS METHOD (TABLE 36.10)

Fertility awareness method requires partner's cooperation. The woman should know the fertile time of her menstrual cycle.

Rhythm Method
This is the only method approved by the Roman Catholic Church. The method is based on identification of the fertile period of a cycle and to abstain from sexual intercourse during that period.


Table 36.10: Fertility awareness Methods (rhythm method). Advantages	Disadvantages
•  No cost.	•  Difficult to calculate the safe •  Lack of side effects.                         period reliably.
•  The period of abstinence is	•  Needs several months determined by calculating              training to use these
the length of the woman's	methods.
previous menstrual cycles.	•  Compulsory abstinence from Three assumptions are                     sexual act during certain considered: (al  Human                  periods.
ovum can be fertilized	•  Not applicable during for about 24 hours after                 lactational amenorrhea ovulation; (bl  Sperm can                or when the periods are
fertilize 3-5 day after coitus;	irregular.
I
I
(cl Ovulation usually occurs
12-16 days before the onset	Failure rate-20-30 (HWY) of menstruation.

This requires partner's cooperation. The methods to determine tlie approximate time of ovulation and the fertile period include­ (a) Recording of previous menstrual cycles (calendar rhythm); (b) Noting the basal body temperature chart (temperature rhythm); (c) Noting excessive mucoid vaginal discharge (mucus rhythm). The users of the calendar method obtain the period of abstinence from calculations based on the previous twelve menstrual cycle records. The first unsafe day is obtained by subtracting 20 days from the length of the shortest cycle and last unsafe day by deducting 10 days from the longest cycle. Users of temperature rhythm require abstinence until the third day of the rise of temperature. Users of mucus rhythm require abstinence on all days of noticeable mucus and for 3 days thereafter.

Coitus lnterruptus (Withdrawal) (Table 36.11)
It is the oldest and probably the most widely accepted contracep­ tive method used by man. It necessitates withdrawal of penis shortly before ejaculation. It requires sufficient self-control by the man so that withdrawal of penis precede ejaculation.

Table 36.11: Coitus interruptus. Advantages	Disadvantages
•  No appliance    •  Requires sufficient self-control by the man is required.        •  The woman may develop anxiety neurosis,
•  No cost.	    vaginismus or pelvic congestion. •  Chance of pregnancy is more:
o  Precoital secretion may contain sperm. o  Accidental chance of sperm.
I
I
Failure rate-20 (HWY)
When the woman is exclusively breastfeeding, a contraceptive method should be used in the 3rd postpartum month  and with partial or no breastfeeding, she should use it in the 3rd postpartum week.
Emergency contraception should be used from 21 day postpartum.


Breastfeeding, Lactational Amenorrhea (LAM)
Prolonged and exclusive (6 months) breastfeeding offer a natural protection against pregnancy. The criteria for successful of LAM are:  Continuous  amenorrhea and exclusive breastfeeding up  to  6 months. Night nursing is highly protective. More effective in women who are amenorrheic than those who

Chapter 36: Population Dynamics and Control of Conception

are menstruating. The risk of pregnancy to a woman who is exclusively breastfeeding for 6 months and amenorrheic is less than 2% in the first 6 months. Otherwise, the failure rate is high (1-10%). Thus during breastfeeding, additional contraceptive support should be given by condom, IUCD or injectable steroids where available, to provide complete contraception.


CONTRACEPTIVE COUNSELING AND PRESCRIPTION


Pregnancy carries an overall maternal mortality around 400 per 100,000 total births in the developing countries (India 167 /100,000 LB) and the  same in the developed countries is less than 10. Whereas annual number of deaths per 100,000 exposed to pill is 1.3 and with that of IUDs is 1. The same from tubal sterilization is 1.2 and vasectomy is 0.1. The risks of death from automobile driving is 1 in 6,000 per year. Contraception usually carries less risk compared to pregnancy. Importantly, benefits of contraceptive use outweigh the risks of pregnancy.
No single universally acceptable method has yet been discovered. The individual should have the liberty to choose any of the currently available well-tested method, which may even vary at each phase in her reproductive life. If one compares the risks and benefits of any contraceptive, it is observed that more deaths occur as a result of unplanned pregnancies than from the hazards of any modern contraceptive method (excluding 'pill' users over 35 who smoke).
Important factors for the selection of any contJ·aceptive method for an individual are-relative safety, effectiveness, side effects, and willingness to use the method correctly and consistently. The other fac­ tors to consider are the frequency of coitus, the need oflactation and prevention ofSTis. Acceptability is probably the most critical factor in the effectiveness of a contraceptive method. Couple (client) should be helped to make an informed choice. A clear account of the risks and the benefits for an individual method is given. Regular follow-up and compliance with the instructions are to be ensured. It is also essential that an informed (verbal) consent is obtained and recorded.

I PRESCRIPTION

Conventional contraceptives can be safely prescribed during the entire reproductive period as elective choice or as an alternative to 'pill' or IUD if they are contraindicated or unacceptable to the couple. As such only the advice regarding the use of 'pill' or IUD during different phases of reproductive life is discussed.

Adolescent Girls
Low-dose combined pills are most effective for the sexually active adolescents. It is the contraceptive of choice. However, DMPA or norplant may be an alternative when accepted. There is no concern about their future reproductive endocrinologic function or the epiphyseal closure in postmenarchal girls.

Newly Married Couple
A highly effective and acceptable contraceptive like DMPA, or POPs, could be prescribed. IUD may not be prescribed. As such COCs are recommended provided there is no contraindication. Apart from effective contraception 'COCs' have got many noncontraceptive benefits as well.

Spacing of Births
■   Postabortal	■ Postpartum	■  Interval


♦   It should be noted that Emergency Contraception is required from 21 days postpartum.
Postabortal
The contraceptive practice should be started within 5 days following the abortion/ectopic management/GTD treatment process is completed. DMPA, POPs or COCs could be a choice. IUD is an alternative.
Postpartum
■   Nonlactating	■	Lactating
Non lactating
Contraceptive practice should be started after 3 weeks. 'POP' is good; IUD is an equally effective alternative. Injectable DMPA could be used as it is devoid of any estrogen-related side effects (DMPA theoretically	risk of VTE if used within 6 weeks of delivery; MEC-2). Implanon (etonogestrel) may be prescribed.
t

Lactating
In fully lactating women (5-6 feeds and spending about 60 minutes in 24 hours), the contraceptive practice may be safely withheld for 6 weeks postpartum. For doubtful adverse effects of steroids on lactation and on the babies through the ingested milk, 'pill' is better withheld. Minipill (POP) or injectable steroid (DMPA) is ideal. Alternatively, IUD can be inserted.
Interval
Below the age of 35 years, she can have her choice to either 'pill' or IUD following adequate counseling. In women above the age of 35, especially who are smokers, IUD should be inserted in preference to 'pill'. Injectables (DMPA) or implant (Implanon) is the other alternative.
To stop future pregnancies: The decision to advise permanent sterilization should be judiciously given, especially to the under­ privileged women in the face of high perinatal and infant mortality rate. The cases are to be individualized. However, a two-child formula is usually recommended and as such, a couple having two children who have been fully immunized can have permanent sterilization (husband or wife). If the couple is not motivated to undergo the sterilization operation, any of the temporary methods is to be prescribed till the end of the reproductive period of the wife. Women who have completed their family but do not desire for permanent sterilization, may use IUD (CU-T 380A) or implant if accepted.

Older Women
Contraception should be prescribed to avoid unplanned pregnancy. Low dose pills can be continued till menopause ( with monitoring) in the low-risk group. Progestin-only pill, injectable progestin (DMPA), LNG-IUS are the other alternatives. Barrier methods and vaginal spermicides can be used either as a primary or back-up method. Usually, fertility is reduced after 40 years ofage.
Chapter 36: Population Dynamics and Control of Conception

Age for stopping contraception.
Type of contraception    40-50 years	>SO years
Non hormonal	Stop after 2 years	Stop after 1 year of of amenorrhoea.	amenorrhoea.
CHC	 May be continued    Stop by SO years. till SO years.	May switch to non
hormonal methods or IMP/POP/LNG IUS.
DMPA	 May be continued    May switch to other till 50 years.	methods
IMP/POP/LNG IUS	 May be continued    Can stop by 55 years. till 50 years.

Women at risk of STis need dual protection against preg­ nancy and STis. They should use condom with spermicides or use another contraceptive (DMPA, COC, or POP), method in conjunction with condom.
Women using enzyme inducers are advised to take COCs having more than usual dosage or other method of contraception (DMPA, IUDs). Emergency contraception  (postcoital contraception) when required as emergency, POP, IUD can be used.

ONGOING TRIALS AND SELECTIVE AVAILABILITY
The following are used on trial basis or are available in selected countries:
■   Combined Injectable Contraceptives (CICs): Both estrogen and progestin are combined in these monthly injectables. Preparations  available  are:  DMPA 25 mg with  estradiol cypionate 5 mg (Cyclofem) and NET-EN 50 mg with estradiol valerate 5 mg (Mesigyna). It is given within first 5 days of menstruation. Next injection should be on the same date of each month ( 4-week schedule). Fertility return is quick.
Drawbacks: (a) Irregular or prolonged menstrual bleeding; (b) Not suitable for nursing mothers. It is has been currently withdrawn from the market.
■  Transdermal patch: Patch contains 0.75  1g ethynyl estradiol and 6 mg norelgestromin. When used as a cream to the skin. It provides effective contraception. Patch delivers 150  1g norgestinate (progestin) and 20  1g ethinylestradiol daily. It has an area of 20 cm2 (4.5 x 4.5 cm). The patch is used weekly for 3 weeks and one week off for withdrawal bleeding. It is well-tolerated, safe and effective.



Advantages: It avoids hepatic first pass metabolic effects and maintains steady serum hormone levels.
Drawbacks: Patch detachment, skin reaction and high failure in overweight women (>90 kg). It is applied over the buttocks, upper and outer arm, or lower abdomen but not over the breasts. Failure rate is 1.2 per 100 women years. Patch failure rate is high in woman weighing >90 kg. Patch may increase the risk ofVTE.
■  Vaginal ring: Containing levonorgestrel covered by silastic tubing has been introduced. They are 5 and 6 cm in diameter. The vaginal ring delivers levonorgestrel (20   1g/day) to maintain a constant blood level like norplant. The rings are replaced by 90 days. Pregnancy rate is 3 per 100 women. This method is under woman's control.
■   Combined  ring  (Nuva  ring):  Soft,  flexible  transparent ethylene vinyl ring releases ethinyl estradiol (15  1g) and etonogestrel (metabolite of desogestrel) 120  1g daily over a period of 21 days. The ring is inserted on the first day of menses and is worn for 3 weeks. The ring must be reinserted within the next 3 hours, if removed for any reason, vaginal route use avoids GI absorption, first pass liver metabolism and has lowest systemic estrogenic side effects. It is then removed and after 1 week (after the withdrawal bleed) a new ring is inserted. It acts by inhibiting ovulation. Pearl index is 0.65 and cycle control is good. The ring (54 mm diameter and 4 mm thick) is inserted within 5 days of menses. Side effects are, headache, leukorrhea, vaginitis, and expulsion.
I TRANSCERVICAL STERILIZATION
Essure is a 4 cm long, 2 mm diameter, microcoil (spring­ like device) made of nickel-titanium steel alloy coil within which lie polyethylene terephthalate fibers. It is inserted into each fallopian tube transcervically using a hystero­ scope. The tube is blocked permanently when scar tissue grows into the device. To ensure proper placement and total occlusion of essure a hysterosalpingogram is done three months after. Its success rate is similar to surgical sterilization ( <l %). For the first 3 months, the woman needs to use a temporary contraceptive method in addi­ tion, till the scar tissue is formed.
Common side effects are: Pelvic pain and abnormal uterine bleeding. Essure contraceptive system is no longer marketed in the United States since 2019.





►   Barrier methods of contraception include condom, diaphragm and vaginal contraceptives (chemicals and sponge today). ►   Natural contraception includes-rhythm method, coitus interruptus, and breastfeeding.
►   Conventional contraceptive methods include use of condom, vaginal diaphragm, spermicidals, and rhythm method. ►   Fertility awareness methods (periodic abstinence) are mostly dependent upon the compliance of use.
►   Barrier methods have high failure rate unless used correctly and consistently. ►  These must be fitted by a health professional.
►   Male condoms can reduce the risk of STls including HIV.
►   Spermicide and microbicide are used as combined agents. In isolation, these should not be used. ►   Lactational amenorrhea is an effective method of contraception. Failure rate is 2 per 100 WY.
►   Contraceptive counseling and prescription-should consider the relative safety, effectiveness, side effects of the method. It is important that the method is used correctly and consistently.
►   It is hard to predict contraceptive trends in the immediate future as the results of contraceptive research are still unclear about the risks and benefits.


Operative Obstetrics








CHAPTER OUTLINE

❖ Dilatation and Evacuation (D & E) ►  One-stage Operation
► Two-stage Operation
►  Management of Uterine Perforation
❖ Suction Evacuation ❖ Vacuum Aspiration ❖ Episiotomy
►  Types
►  Steps, Postoperative Care ►  Complications
❖ Operative Vaginal Delivery


►  Forceps
►  Types of Forceps Operation ►  Low, Outlet and Midforceps ►  Difficulties in Forceps
Operation
►  Kielland's Forceps
►  Complications of Forceps Operation
❖ Ventouse ❖ Version
►  External Cephalic Version ►  Internal Version


❖ Cesarean Section (CS) ►  Indications
►  Lower Segment CS ►  Postoperative Care
►  Classical Cesarean Section
►  Complications of CS: lntraoperative, Postoperative
❖ Destructive Operations
►  Craniotomy, Cleidotomy ►  Postoperative Care
❖ Symphysiotomy




Obstetric operations are surgical procedures and as such irrespective of the nature of operation (major or minor), asepsis and antiseptic precautions are to be taken as outlined  below.  Even  an  internal  examination  during late pregnancy and labor requires utmost asepsis. The proximity of the bladder and rectum to the operative field should deserve attention prior to any operative procedure.
Before proceeding to vaginal operative or manipulative obstetrics, some protocols are to be maintained. While a uniform guideline is difficult to formulate, the following preliminaries are to be followed with a few additions or alterations as and when required. These are:
1.  Anesthesia-either  general  or  local  is  used.  In some cases,  the operation may be performed with intravenous diazepam sedation.
2.  The patient is to be placed in lithotomy position. 3.  Full surgical asepsis is to be taken:
a.  Surgical team is to wear sterile cap, mask, thorough handwash and to wear gown and gloves
b. Vulva and vagina are to be swabbed with antiseptic solution
c.  Cervix is cleaned with povidone-iodine solution
d. The perineum is to be draped by sterile towel and the legs with leggings.
4.  To empty the bladder-if the patient is ambulant, she is asked to empty the bladder before she is placed on the table; otherwise catheterization is to be done.
5.  Vaginal examination is done.


DILATATION AND EVACUATION (D & E)

The operation consists of dilatation of the cervix and evacuation of the products of conception from the uterine cavity. The operation may be performed:
♦  One stage: Dilatation of the cervix and evacuation of the uterus are done in the same sitting.
♦  Two stages:
a.  First phase includes slow dilatation of the cervix.
b.  Second phase includes rapid dilatation of the cervix and evacuation.
I ONE-STAGE OPERATION
INDICATIONS: (1) Incomplete abortion (most common); (2)  Inevitable  abortion;  (3)  Medical  termination  of pregnancy (6-8 weeks); and (4) Hydatidiform mole in the process of expulsion.
PROCEDURES
Preliminaries:  The  steps  to  be  followed  are  those mentioned  earlier.  The  patient  is  put  under  general anesthesia. Internal examination is done to note the size and position of the uterus and state of dilatation of the cervix.
Steps (Incomplete abortion-recent):
1.  If the cervix is not sufficiently dilated to admit the index finger (usually it does), it should be dilated.
2.  Sim's  posterior  vaginal  speculum  is  introduced  and an assistant is  asked to hold it. The anterior lip of the cervix is grasped by an Allis forceps to steady the cervix.
:I Chapter 37: Operative Obstetrics
Uterine sound is not to be introduced. Sounding provides no information but risks perforation and bleeding.

3.  The cervical canal is gradually dilated up to the desired extent by the graduated metal dilators (Figs. 42.12A and B).
4.  The products are removed by ovum forceps. The uterine cavity  is  finally  curetted  gently  by  a  flushing  (blunt) curette. Injection methergine 0.2 mg is to be administered intravenously during the procedure.
5.  The speculum and the Allis forceps are to be removed. The uterus is to be massaged bimanually with the help of the external hand and the internal fingers placed inside the vagina.
6.  After being satisfied that the uterus is firm and the bleeding is minimal, the vagina and per!neum are toileted; a sterile vulva! pad is placed and the patient is sent back to her bed.



-





;--- The swollen
laminaria and
soft dilated cervix several
hours later



Postabortion care includes: (a) Emergency treatment of complications of any abortion spontaneous or induced; (b) Family planning counseling and referral services; and (c) Linkages to other reproductive health services (comp­ rehensive services). Male partner should be involved.

I TWO-STAGE OPERATION
INDICATIONS:  (1)  Induction of first trimester abortion  (most common);  (2)  missed abortion (uterus 8-10 weeks);  and  (3) hydatidiform mole with unfavorable cervix (long, firm and closed os). To prevent damage to the cervix during rapid dilatation, a two-stage operation is however preferred in such cases.
PROCEDURES
(A) First phase: It consists of introduction of laminaria
tents or lamicel (MgSO 4  sponge) into the cervical canal to effect its slow dilatation. The same may be effective
by intravaginal insertion of misoprostol (PGE1), 400 µg 3 hours before surgery. It has less side effects.
Steps of introduction of tents: The preliminaries to be followed are those mentioned earlier (p. 525). (a) The patient should empty her bladder beforehand;  {b) No anesthesia is required; and (c) The appropriate size and number of the tent required are selected. The threads attached to one end are tied to the roller gauze.
Steps:
1.  Internal examination is done to note the size and position of the uterus and state of the cervix.
2.  Sim's posterior  vaginal speculum  is introduced  and  an assistant is asked to hold it. The anterior lip of the cervix is grasped by an Allis forceps to steady the cervix.
3.  The cervical  canal  may  have to be  dilated  especially in primigravidae by one or two smaller metal dilators (Hawkin Ambler: size 3/6 or 4/7) to facilitate the introduction of the tents.
4.  The tents are introduced one after the other, holding it by tent introducing forceps (Figs. 37.IA and B). The tents should be introduced for at least 4 cm (1.5'), so that the tips are placed beyond the internal os. The tents can also be introduced manually.
5.  The roller gauze is used to pack the upper vagina so as to prevent the displacement of the tents.



Figs.  37.1A  and  B:  Laminaria  tent:  (A)  Prior  to  introduction; (Bl  Marked  swelling  due  to hygroscopic  action  while  kept  in cervical canal.

6.  The patient is returned to her bed.
7.  Prophylactic antibiotic (doxycycline 100 mg PO BID for 3 days and metronidazole PO 400 mg BID for 5 days) is usually administered.
(B) Second phase: It consists of further dilatation of the cerix by graduated metal dilators followed by evacuation of the uterus.
Procedures
■  The patient is brought back to the operation theater usually after 12 hours. The patient should empty her bladder beforehand.
■  Preliminaries: The steps to be followed  are those previously  mentioned.   The   operation   may  be conducted under intravenous diazepam sedation, local paracervical block or under general anesthesia.

Steps (MTP-8 weeks)
1.  The posterior vaginal speculum is introduced after removing the roller gauze. The tents are removed with the help of sponge forceps. The vagina and the cervix are swabbed with antiseptic (povidone-iodine) solution. The posterior vaginal speculum is removed.
2.  Vaginal examination is done to note the size of the uterus, position of the uterus and state of dilatation of the cervix.
3.  Posterior vaginal speculum is reintroduced and is to be held by an assistant. The anterior lip of the cervix is to be grasped by the Allis forceps to steady the cervix.
4.  The cervix is dilated with the graduated metal dilators up to the desired extent (10/13-12/15) to facilitate introduction of the ovum forceps.
5.  The products are removed by introducing the ovum forceps. Intravenous methergine 0.2 mg is to be given during this stage to minimize blood loss. Firm and well-contracted uterus facilitates curettage (Fig. 37.2).
6.  The uterine cavity is thoroughly curetted by a flushing curette.





The cannula is rotated and moved in and out
I·

J;Cs' "'o/:'.

Chapter 37: Operative Obstetrics	& Ho. is helpful to assess the size and site of perforation and the
"'
r'
!
f
amount of hemorrhage. Operative laparoscopy or laparotomy may be needed to tackle the situation. One should not forget to inspect the intestine or omentum for evidence of injury.

♦   Lateral cervical tear with broad ligament hematoma or laceration of uterine artery: Laparotomy followed by repair (conservative surgery) or hysterectomy.







Fig. 37.2: Suction evacuation.

7.  The  posterior  vaginal  speculum  and  Allis  forceps  are removed. The uterus is massaged bimanually and after being satisfied that the uterus is empty (evidenced by a well­ contracted uterus with minimal bleeding), the patient is sent to her bed after placing a sterile vulva! pad.
8.  Oxytocic  agents:  Injection  methergine  0.2  mg  IM  is given. Alternatively, oxytocin 20 units in 500 mL of normal saline IV is given intraoperatively and continued after the operation for 30 minutes.
9.  Prophylactic antibiotics (doxycycline and metronidazole) are prescribed.

COMPLICATIONS OF D & E OPERATION

Immediate:  (1)  Excessive hemorrhage-may be due to:  (a)  Incomplete  evacuation,  or  (b)  atonic  uterus; (2) Injury-(a) Cervical lacerations of varying degrees which  may  lead  to  formation  of  a  broad  ligament hematoma; and (b) Uterine perforation;  (3) Shock due to: (a) Local anesthesia-convulsions, cardiorespiratory arrest, death due to intravascular injection or over dose, (b) Excessive blood loss, (c) Cervical shock-vasovagal syncope due to cervical stimulation; (4) Perforation­ injury to major blood vessels, bowel or bladder. Risk is more with advanced gestation; (5) Sepsis-endometritis, myometritis  and  pelvic peritonitis;  (6)  Hematometra may  cause  pain;  (7)  Increased  morbidity;  and  (8) Continuation of pregnancy (failure)-1 %.
Late:  (1)  Pelvic  inflammation;  (2)  Infertility;  (3) Cervical  incompetence;  (4)  Uterine synechiae and in subsequent  pregnancy risks: (5) Preterm labor; and (6) Ectopic pregnancy.

MANAGEMEN T PROTOCOL OF UTERINE PERFORATION
The management depends on the location, size and nature of the instrument causing the perforation.
♦   The procedure is stopped.
♦   Perforation made by small instruments, such as sound or smaller size dilator-expectant treatment with observation of pulse and blood pressure. Antibiotic is to be given.
♦   Perforation  caused  by  bigger  size  dilator  or  ovum  or ring  forceps  or  suction  cannula:  Diagnostic  laparoscopy

♦   Perforation prior to complete evacuation: Any of the following may be followed-(a) To stop evacuation, vaginal evacuation can be done under laparoscopic visualization; (b) Iflaparotomy is  decided:  (i) Complete the evacuation either through the rent or anterior hysterotomy, if preservation of the uterus is necessa1y; and (ii) Hysterectomy-if family is completed.
Along with the definitive surge1y1 simultaneous resuscitative procedure and administration of antibiotics are mandatmy.

SUCTION EVACUATION (SE)

It is a procedure in which the products of conception are  sucked  out  from  the  uterus  with  the  help  of a  cannula  fitted  to  a  suction  apparatus.   Suction evacuation (suction curettage) is a transcervical approach of surgical abortion. Cervix is first dilated and then the products of conception are evacuated.
INDICATIONS:  (1)  Medical  termination  of pregnancy during first trimester  (most common);  (2)  Inevitable abortion;  (3)  Recent  incomplete  abortion;  and  ( 4) Hydatidiform mole.
PROCEDURES: Preliminaries: The steps to be followed are those mentioned above. General anesthesia is usually not needed. If the patient is apprehensive, intravenous diazepam 5-10 mg (conscious sedation) supplemented by intracervical block is quite effective. The patient is put on the table after she empties her bladder.
5 mL of 1 % lidocaine is injected at 12, 3, 6 and 9 o'clock. Otherwise regional anesthesia may be given.
Steps (Fig. 37.2)
1. Vaginal examination is done to note the size and position of the uterus and also the state of cervix.  USG (TAS/TVS) should be  performed when  there is any doubt about the gestational age.
2. Posterior vaginal speculum  (Fig. 42.4) is introduced and an assistant is asked to hold it.
3.  The anterior lip of the cervix is to be grasped by an Allis forceps. A uterine sound is to be introduced to note the length of the uterine cavity and position of the uterus.
4.  The cervix may have to be dilated with smaller size graduated metal dilators up to one size less than that of the suction cannula. Feeling of  'snap'  of the  endocervix  around  the dilator is  characteristic.  Instead  laminaria  tent  12  hours
before  (osmotic  dilator)  or  misoprostol  (PGE1)  400   tg given vaginally 3 hours prior to surge1y produces effective
dilatation.
5. Intravenous methergine 0.2 mg is administered.
6. The appropriate suction cannula (Fig. 42.22) is fitted to the suction apparatus by a thick rubber or plastic tubing. The cannula is then introduced into the uterus, the tip is to be placed in the middle of the uterine cavity.
ml Chapter 37: Operative Obstetrics

7.  The pressure of the suction is raised to 400-600 mm Hg. The cannula (Karman) is moved up and down and rotated within the uterine cavity (360°) with the pressure on. The suction bottle is inspected for the products of conception and blood loss. The suction is regulated by a finger placed over a hole at the base of the cannula.
The endpoint of suction is denoted by: a.  No more material is being sucked out.
b.  Gripping of the cannula by the contracting smaller size uterus.
c.  Grating sensation.
d. Appearance  of  bubbles  in  the  cannula  or  in  the transparent tubing.
8.  The vacuum should be broken before withdrawing the cannula down through the cervical canal to prevent inju1y to the internal os.
9. It is better to curette the uterine cavity by a small flushing curette at the end of suction and the cannula is reintroduced to suck out any remnants.
10. After being satisfied that the uterus is remaining firm, and there is minimal vaginal bleeding, the patient is brought down from the table after placing a sterile vulva! pad.
Use of USG during the procedure shortens the operative time and reduces complications.
The operator should examine the aspirated tissue by floating it in a clear plastic dish over a light source. Placental tissue appears fluffy and feathe1y when floats in normal saline. This will help to detect failed abortion, molar pregnancy or ectopic pregnancy. The procedure is contraindicated in advanced pregnancy and in the presence of local pelvic inflammation. There is risk of continuation of pregnancy (0.5-2%) and ectopic pregnancy. When no chorionic villi are found on tissue examination, ectopic pregnancy should be excluded by estimation of hCG levels and vaginal ultrasonography.

VACUUM ASPIRATION
This procedure is  similar  to  suction evacuation and is done as outpatient basis. The procedure may be Manual Vacuum Aspiration (MVA) or Electric Vacuum Aspiration (EVA) and is highly effective (98-100%). Termination of
















Figs. 37.3A and B: Manual vacuum aspiration (MVA) syringe with cannula (details: Ch. 42, Figs. 42.21  and 42.22).

pregnancy is done up to 12 weeks with minimal cervical dilatation (Figs. 37.3A and B). A hand-operated double valve plastic syringe (60 mL) is attached to a Karman's cannula (up to 12 mm size). The cannula is inserted transcervically into the uterus and the vacuum is activated. A negative pressure of 660 mm Hg is created. Aspiration of the products of conception is done. This procedure takes less time (5-15 minutes) and is less traumatic. Complications are similar to other surgical methods but are less severe.
COMPLICATIONS: Use of a plastic cannula can minimize uterine perforation.   Complications  increase   with  gestational  age. Common complications are:  hemorrhage, retained products of conception perforation and postoperative infections.

HYSTEROTOMY

Hysterotomy is an operative procedure of extracting the products of conception out of the womb before viability (28th week) by cutting through the anterior wall of the uterus. The operation is  usually done through the abdominal route. This operation is rarely done these days for the purpose of MTP.
INDICATIONS:  (1)   Midtrimester  MTP  where  other methods have failed or are contraindicated, (2) Fibroids in the  lower  uterine  segment  obstructing evacuation, (3) Completely low-lying placenta (placenta previa), (4) Uterine anomalies  (uterine didelphys,  septate uterus) (5) Ce1vical cancer with pregnancy, and (6) Women with multiple previous cesarean deliveries ( due to the risk of placenta accreta).
STEPS (ABDOMINAL HYSTEROTOMY): The preparation is similar to that of any other major surgical operation. The anesthesia is  either general or epidural. The  abdomen is opened  either through a low transverse or infraumbilical vertical incision above the symphysis pubis.
Step I: The uterus is drawn out of the incision. The abdominal cavity and the abdominal wall are to be well packed to prevent contamination by the products of conception (to minimize scar endometriosis). If there is difficulty in delivering the uterus out of the abdomen, it can be done with a finger hooked through the uterine incision.
Step II: Methergine 0.2 mg is given intravenously. The loose peritoneum of the uterovesical pouch is cut transversely and pushed up and down (Figs. 37.23A and B). The myometrium is cut vertically for about 5 cm (2") deep enough to make the membranes visible. Alternatively, the uterine incision may be vertical in the middle of the body of the uterus as low down as possible.
Step III: The products of conception are gently taken out; the cavity is cleaned with a gauze covered finger.
Step IV: The uterine incision is closed in three layers: ( a) Deeper myometrium excluding the decidua is apposed by continuous sutures using No. '0' catgut and round bodied needle; (b) similar second layer of continuous suture is employed taking the entire thickness of the muscle down to the first layer of suture; and ( c) the peritoneum is apposed transversely using continuous suture.
Step V: Packs are removed; peritoneal toileting is done; another dose of methergine 0.2 mg is administered intramuscularly and the abdominal wall is closed in layers.
Chapter 37: Operative Obstetrics	ml

COMPLICATIONS:  ♦  Immediate    +  Remote ♦   Immediate:
1.  Uterine bleeding 2.  Peritonitis
3.  Intestinal obstruction 4.  Anesthetic hazards.
All these lead to increased morbidity and an occasional death.
♦    Remote:
1.  Menstrual abnormality-menorrhagia or irregular periods.
2.  Scar endometriosis (1 %).
3.  Scar rupture in subsequent pregnancy. Concurrent sterilization reduces the hazards.

EPISIOTOMY
DEFINITION:  A  surgically  planned  incision  on  the perineum and the posterior vaginal wall during the second stage oflabor is called episiotomy (perineotomy). It is in fact an inflicted second-degree perinea! injmy. It is the most common obstetric operation performed.
OBJECTIVES
♦    To enlarge  the  vaginal introitus so as to facilitate easy and safe delivery of the fetus: spontaneous or manipulative.
♦    To  minimize  overstretching  and  rupture  of  the perinea! muscles and fascia.
♦    To reduce the stress and strain on the fetal head.

INDICATIONS: Episiotomy is recommended in selective cases rather than as a routine (Box 37.1).
Timing of the episiotomy: The timing of performing the  episiotomy  requires judgment.  If done  early,  the blood loss will be more. If done late, it fails to prevent the invisible lacerations of the perinea! body and thereby fails to protect the pelvic floor-the very purpose of the episiotomy is thus defeated. Bulging thinned perineum

during contraction just  prior to crowning  (when 3-4 cm of head is visible) is the ideal time. During forceps delivery, it is made after the application of blades.

ADVANTAGES
♦    Maternal:  It  is  controversial  whether  routine  ep1s10tomy has got any major benefits. The suggested benefits are:  (a) A clear and  controlled incision is easy to repair and heals better than a lacerated wound that might occur othe1wise; {b) Shortening in the  duration  of second stage;  and  (c) Reduction of trauma to the pelvic floor muscles-that reduces the incidence of prolapse and perhaps urinary incontinence.
♦    Fetal:  It  minimizes   intracranial   injuries   especially   in premature babies or aftercoming head of breech.
II TYPES
The  following  are  the  various  types  of  episiotomy {Figs. 37.4A and B):
•   Mediolateral	•   Median
•   Lateral	•   'J' shaped
Mediolateral: The incision is made downwards and outwards from the midpoint (60°  off the midline) of the fourchette either to the right or to the left. It is directed diagonally  in  a  straight  line  which  runs  about  2.5  cm away from the anus {midpoint between anus and ischial tuberosity).
Median: The incision commences from the center of the fourchette and extends posteriorly along the midline for about 2.5 cm (Table 37.1).


■   Rigid inelastic perineum:  Causing arrest  or  delay in descent
of the presenting part as in elderly primigravidae.
•   Anticipating  perinea! tear:  (a)  Big  baby,  (b)  Face-to-pubis
delivery,  (c)   Breech  delivery,  (d)  Shoulder dystocia,  and  (e)
Persistent occiput posterior.
■  Operative delivery: Forceps delivery, ventouse delivery.
■   Previous perinea! surgery: Pelvic floor repair, perinea! recon­
structive surgery.


















Figs. 37.4A and B: Steps of mediolateral episiotomy: (A) Perinea! infiltration;  (Bl Cutting the perineum.
Chapter 37: Operative Obstetrics


Table 37 .1: Relative merits and demerits of median and mediolateral episiotomy.
Median	Mediolateral
Merits	• The muscles are not cut.   n   Relative safety from
•
•
•
Blood loss is least.	rectal involvement
Repair is easy.	from extension.
Postoperative comfort	■   If necessary, the is maximum.                          incision can be
■  Healing is superior.	extended. ■  Wound disruption is
rare.
■   Dyspareunia is rare.
Demerits    ■  Extension, if occurs,	■  Apposition of the may involve the rectum.       tissues is not so good.
•
■  Not suitable for	Blood loss is little more.
manipulative delivery	■  Postoperative
or in abnormal	discomfort is more. presentation or                 ■  Relative increased position. As such, its	incidence of wound
use is selective.	disruption.
■  Dyspareunia is comparatively more.


Lateral: The incision starts from about 1 cm away from the center of the fourchette and extends laterally. It has got many drawbacks including chance of injury  to the Bartholin's duct. It is totally condemned.
'/' shaped: The incision begins in the center of the fourchette and is directed posteriorly along the midline for about  1.5  cm  and then  directed  downwards and outwards along 5 or 7 o'clock position to avoid the anal sphincter. Apposition is not perfect and the repaired wound  tends  to  be  puckered.  This  is  also  not  done widely.
Thus, only mediolateral or median episiotomy is done commonly and as such their relative merits and demerits are given in the tabulated form (Table 37.1).

I STEPS OF MEDIOLATERAL EPISIOTOMY

STEP I: Preliminaries-the perineum is thoroughly swabbed with antiseptic (povidone-iodine) lotion and draped properly. Local anesthesia: The perineum, in the line of proposed incision is infiltrated with 10 mL of 1 % solution oflignocaine.
STEP II: Incision-two fingers are placed in the vagina between the presenting part and the posterior vaginal wall. The incision is made by a curved or straight blunt pointed sharp scissors (scalpel may also be used), one blade of which is placed inside in between the fingers and the posterior vaginal wall and the other on the skin. The incision should be made at the height of an uterine contraction when an accurate idea of the extent of incision can be better judged from the stretched perineum. Deliberate cut should be made starting from the center of the fourchette extending laterally either to the right or to the left. It is directed diagonally in a straight line which runs about 2.5 cm away from the anus. The incision ought to be adequate to serve the purpose for which it is needed, i.e., according to the need

of the individual case. The bleeding is usually not sufficient to use artery forceps unless the operation is done too early 01; the perineum is thick (Figs. 37.4A and B).
Strnctmes cut are (Fig. 37 .5): (1) Posterior vaginal wall, (2) Superficial and deep transverse perinea! muscles, bulbospongiosus and part of levator ani; (3) Fascia covering those muscles; ( 4) Transverse perinea! branches of pudenda! vessels and nerves; (5) Subcutaneous tissue and skin.
STEP III: Repair-timing ofrepair: The repair is done soon after expulsion of placenta. If repair is done prior to that, disruption of the wound is inevitable, if subsequent manual removal or exploration of the genital tract is needed. Oozing during this period should be controlled by pressure with a sterile gauze swab and bleeding by the artery forceps. Early repair prevents sepsis and eliminates the patient's prolonged apprehension of'stitches'.
Preliminaries: The patient is placed in lithotomy position. A good light source from behind is needed. The perineum including the wound area is cleansed with antiseptic solution. Blood clots are removed from the vagina and the wound area. The patient is draped properly and repair should be done under strict aseptic precautions. If the repair field is obscured by oozing of blood from above, a vaginal pack may be inserted and is placed high up. Do not forget to remove the pack after the repair is completed.
Repair (Figs. 37.6A to E): The repair is done in three layers. The principles to be followed are:  (1) Perfect hemostasis; (2) To obliterate the dead space; and (3) Suture without tension.
The repair is to be done in the following order: 1. Vaginal mucosa and submucosal tissues
2.  Perinea! muscles
3.  Skin and subcutaneous tissues. Preliminaries had been discussed on p. 523.
The vaginal mucosa is sutured first. The first suture is placed at or just above the apex of the tear. Thereafter, the vaginal walls are apposed by interrupted sutures with polyglycolic acid suture (Dexon) or No. 'O' chromic catgut, from above downwards till the fourchette is reached. The suture should include the deep tissues to obliterate the dead space. A continuous suture may cause puckering and shortening of the posterior vaginal wall. Care should be taken not to injure the rectum. Rest of the procedure is discussed before (see 'repair of complete perinea! tear' in p. 398).

I POSTOPERATIVE CARE
Dressing: The wound is to be dressed each time following urination and defecation to keep the area clean and dry. The  dressing is done by swabbing  with cotton swabs soaked in antiseptic solution (povidone-iodine) followed by application of antiseptic powder or ointment (furacin or neosporin).
Pain: To relieve pain in the area, MgSO 4 compression or application of infrared heat may be used. Ice packs reduce
swelling and pain also. Analgesic drugs (ibuprofen) may be given when required.
Ambulance: The patient is allowed to move out of the bed after 24 hours. Prior to that, she is allowed to roll over onto her side or even to sit but only with thighs apposed.



lschiocavernosus muscle

Bulbospongiosus muscle

Internal pudenda! artery

Urogenital diaphragm
Superficial transverse
perinea! muscle

Chapter 37: Operative Obstetrics	ml -·· Urethral meatus
Branches of pudenda! nerve

Lateral episiotomy

Mediolateral episiotomy

Median episiotomy
1''%"---	--   Inferior hemorrhoidal nerve



Levator ani muscle

Exterior sphincter
ani muscle


 =4 =--= - Perforating
cutaneous nerve


Fig. 37.5: Diagrammatic representation of the structures to be cut in different types of episiotomy.


















Figs. 37.6A to E: Steps of repair of episiotomy: (A) Wound on inspection; (B) Repair of vaginal mucosa; (C) Repair of perinea! muscles by interrupted sutures; (D) Apposition  of the skin margins; (E) Repaired wound on inspection.


Removal of stitches: When the wound is sutured by catgut or Dexon which will be absorbed, the sutures need not be removed. But if nonabsorbable material like silk or nylon is used, the stitches are to be cut on 6th day. The number of stitches removed should be checked with the record of the stitches given.
I COMPLICATIONS OF EPISIOTOMY
♦   Immediate	♦	Remote
Immediate: (1) Extension of the incision to involve the rectum. This is likely in median episiotomy or during delivery of  undiagnosed  occipitoposterior even with small mediolateral episiotomy; (2) vulval hematoma; (3)
infection: The clinical features are-(a) Throbbing pain on the perineum, (h) Rise in temperature, (c) The wound area looks moist,  red and swollen,  and  (d) Offensive discharge comes out through the wound margins.
Treatment: ( a) To facilitate drainage of pus by cutting one or two stitches, (b) Local dressing with antiseptic powder or ointment,
( c) MgSO4 compression or application of infrared heat to the area to reduce edema and pain, (d) Systemic antibiotic (IV).


(4) Wound dehiscence is often due to infection, hematoma formation or faulty repair. The wound should be dressed daily until the local infection subsides and healthy granulation tissue forms in the margins. Secondary, sutures are given under local anesthesia using cutting needle and nylon. The margins are to be saucerized and debridement of all necrotic tissues should be done. This is followed by through-and-through sutures taking tissues right at the bottom of the wound. Usual postoperative dressing is to be given. Systemic (IV) antibiotic is prescribed. (5) Injury to anal sphincter causing incontinence of flatus or feces. ( 6) Rectovaginal fistula and rarely. (7) Necrotizing fasciitis (rare) in a woman who is diabetic or immunocompromised.
Remote: (I)  Dyspareunia-this is due to a narrow vaginal introitus which may result from faulty technique of repair or due to painful perineal scar; (2) Chance of perineal lacerations in subsequent labor, if not managed properly; and (3) Scar endometriosis (rare).

OPERATIVE VAGINAL DELIVERY
Operative vaginal delivery refers to any delivery process which  is  assisted  by  vaginal operations.  Delivery by
!I  Chapter 37: Operative Obstetrics


forceps, ventouse and destructive operations are generally included.  Obstetric  maneuvers  (shoulder dystocia­ p. 383) are described under assisted vaginal delivery.

I FORCEPS
Obstetric forceps is a pair of instruments especially designed to assist  extraction  of the  fetal head  and thereby accomplishing delivery of the fetus (Box 37.2 and Table 37.2).
VARIETIES OF OBSTETRIC FORCEPS: Ever since either Peter I or Peter II of the Chamberlen family invented the forceps around AD 1600, more than 700 varieties were invented or modified. Most of them are of historical interest only. But only three varieties are commonly used in present day obstetric practice (Figs. 37.7A to D). These are:
■   Long-curved forceps with or without axis-traction device
■   Short-curved forceps ■   Kielland's forceps
The basic construction of these forceps is the same in that each consists of two halves (blades) articulated by a lock.
I LONG-CURVED OBSTETRIC FORCEPS
Long-curved obstetric forceps is relatively heavy and is about 37 cm (15") long. In India, Das's variety (named after  Sir  Kedar  Nath  Das)  is  commonly  used  with advantages. It is comparatively lighter and slightly shorter than its Western  counterpart  but is quite suited for the comparatively small pelvis and small baby oflndian women.


•   Traction force: In primigravidae, the traction force required is about 20 kg and that in multiparae about 13 kg.
♦   Rotation of the head: Can be achieved by Kielland's forceps.
•   Acts as a protective cage for the head from the pressure of the birth canal as in a premature baby.
•   Controlled delivery  of the aftercoming  head in  breech  to lessen the dangers of sudden decompression.
♦   One forceps blade may be used as a vectis to deliver head in cesarean section.
•   The compression effect of forceps, on the cranium should be minimal  when correctly applied  over  the biparietal, bimalar placement, and should not be more than required to grasp the
fetal head.


Measurements: Length is 37 cm; distance in between the tips is 2.5 cm and widest diameter between the blades is9 cm.
BLADES: There are two blades and are named right or left in relation to maternal pelvis in which they lie when applied.  Each blade consists of the  following parts: (1) Blade; (2) Shank; (3) Lock; and (4) Handle with or without screw.
Blade: The blade is fenestrated to facilitate a good grip of the fetal head. There is usually a slot in the lower part of the fenestrum of the blades to allow the upper end of the axis-traction rod to be fitted.































Figs.  37.7A  to  D:  Different  types  of  obstetric  forceps currently used:  (A)  Long-curved  with  axis  traction  device;  (B) The  same with attached axis traction device; (C) Wrigley's; (D) Kielland's.


Table 37.2: Indications for assisted vaginal delivery (forceps/ventouse).

Maternal
• Inadequate expulsive efforts.
•
Maternal exhaustion (distress).
■  Where expulsive efforts (Va Isa Iva) are to be avoided (e.g., cardiac disease, hypertensive crises, cerebrovascular diseases, spinal cord injury).

[RA = Regional Anesthesia]


Fetal
•  Nonreassuring fetal heart rate (CTG)-(e.g., low birth weight
baby, postmaturity).
■   Aftercoming head of breech.
•
Liquor-meconium stained .


Others
II      Nonprogress of labor beyond the cut-off value: Normal second stage-primi 3 hours with RA or 2 hours without RA. For multi 2 hours or 1 hour respectively.
■   To cut short the second stage of labor as in severe pre-eclampsia, cardiac disease, postcesarean pregnancy.
Chapter 37: Operative Obstetrics    ml

The toe of the blade refers to the tip and the heel to the end of the blade that is attached to the shank.
The blade has got two curves {Fig. 37.8):
1.  Pelvic  curve:  The curve on the edge is to  fit more or less the curve on the axis of the birth canal ( curve of Carus). It forms a part of a circle whose radius is 17.5 cm (7"). The front of the forceps is the concave side of the pelvic curve. Pelvic curve permits ease of application along the maternal pelvic axis.
2.  Cephalic  curve:  It is the curve on the  flat  surface which when articulated, grasps the fetal head without compression. The radius of the curve is 11.5 cm ( 4.5"). Shanie:  It  is  the  part  between  the  blade  and  the lock and usually measures 6.25 cm (2.5"). It increases the length of the instrument and, thereby, facilitates locking of the blades outside the vulva. When the blades
are articulated, the shanks are not apposed together. Lock: The common method of articulation consists
of a socket system located on the shank at its junction with the handle (English lock). Such type of lock requires introduction of the left blade first.
Handle: The handles are apposed  when the blades are articulated. It measures 12.5 cm (5"). There is a finger guard on which a finger can be placed during traction.
A screw is attached usually at the end (or at the base) of one blade (commonly left). It helps to keep the blades in position.
AXIS  TRACTION  DEVICE:  It can be applied with advantage in midforceps  operation especially following  manual  rotation  of the head. It provides traction in the correct axis of the pelvic curve and as such less force is necessaiy to deliver the head. It consists of: (1) Traction rods (two-right and left); (2) Traction handle (Fig. 42.26).
Identification of the traction rods-right or left? Hold the knob pointing inwards and let the rod hang. The small transverse bar at the bottom is to be directed forward.











     I)
Ql  -0
OJ   
C    ll
·-    :,
LL    OJ

m



Fig. 37.8: Different parts of a long-curved obstetric forceps.

The groove attached to the bar is pointing to the side (in relation to the maternal pelvis) to which the traction rod belongs and accordingly the same is attached to the corresponding blade of the forceps.

HOW TO IDENTIFY THE BLADES?
When articulated: Place the instrument in front of the pelvis with the tip of the blades pointing upwards and the concave side of the pelvic curve fo1ward. The blade which corresponds to the left of the maternal pelvis is the left blade and that to the right side is the right blade.