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Advances in Methods of Emergency Contraception

AIIMS Research on Medical Abortion
– Dr Suneeta Mittal Professor & Head, Department of Obstetrics & Gynaecology, AIIMS

Medical abortion offers an important alternative to surgical abortion for women with
early pregnancies who wish to avoid a surgical procedure.technologies.surgical procedure. AIIMS has been conducting research on medical abortion since initiation in 1970s for development of a medical method of terminating pregnancy. The programme of research began by testing the use of prostaglandins alone. The prostaglandin compounds available at that time (sulprostone, gemeprost and meteneprost) were effective only at such high doses that they produced unacceptable side-effects. When the antiprogestin, Mifepristone became available in early 1980s, researchers found that it was not effective when used alone. When used in conjunction with sulprostone, gemeprost or misoprostol, it showed great promise as an alternative to surgical abortion. The standard sequential regimen nowadays is 200 mg mifepristone (up to seven weeks pregnancy) followed 36 to 48 hours later by two 200 µg tablets of misoprostol or 1 mg gemeprost vaginal pessary.

Research Projects undertaken at AIIMS include:

1. Comparative study of different prostaglandins as abortifacients for termination of late pregnancy between 16 to 20 weeks in the year1975. Intraamniotic PGF2a 40mg versus 15 methyl PGF2a 25 mg intramuscular versus extraamniotic 15 methyl PGF2a 50µg had a success rate of 85%, 100% and 96% respectively and a nearly similar induction abortion interval of around 18 hours.

2. Comparative study of Sulprostone 500 µg (Prostaglandin analogue) followed by 1000 µg 4 hours later versus vacuum aspiration for termination of early pregnancy (35-45 days) in 40women in 1983 had a success rate of 85% and 100% respectively.

3. Comparative study of methods of pre-abortion cervical ripening-isaptent, laminaria and intramuscular PGF2a for termination of early pregnancy (POG 8 to 12 weeks) in 1983. Mean cervical dilatation achieved with isaptent, laminaria and intramuscular PGF2a was 10.15 mm, 10.25 mm and 10.10 mm respectively.

4. A WHO multicentric trial in 1989 used mifepristone and sulprostone combination for termination of early pregnancy up to 49 days gestation. Total 251 women were recruited, 40 from India. They were divided into 2 groups. Group I received mifepristone 25 mg b.i.d for 3 days, Group II received mifepristone 25 mg b.i.d for 4 days. Both groups received injection sulprostone 250 µg on D3.

5. A WHO multicentric, randomized, double blind, placebo controlled trial using three misoprostol regimens after pre-treatment with mifepristone for termination of pregnancy up to 63 days from 1998- 2000. Success rate was nearly 96 to 98% in all the groups.

6. Comparative study of vaginal misoprostol 800 µg single dose versus intraamniotic prostodin (15 methyl PGF2 a 2.5 mg for termination of pregnancy between 14 to 20 weeks (2001-2002). Complete abortion rate within 48 hours was 97.5% and 75%, induction abortion interval 16.3 and 21.3 hours for misoprostol and intraamniotic prostodin respectively.

7. Cervical ripening with sublingual misoprostol 400 µg versus placebo in early pregnancy (6 to 11weeks) prior to surgical evacuation (2002). Mean cervical dilatation achieved was 7.7 mm and 3.4 mm with misoprostol and placebo respectively.

8. Comparative study of sublingual versus vaginal misoprostol 400 µg for cervical ripening in early pregnancy (6 to 11 weeks) prior to surgical evacuation (2002). Mean cervical dilatation achieved with vaginal and sublingual misoprostol was 6.8 mm and 8.6 mm, respectively.

Besides completed studies several other research trials on medical abortion are being conducted or planned to be carriedout at AIIMS (Table 5.2.1)

Main outcome measures being evaluated are effectiveness of the procedure (i.e. complete medical abortion without surgical intervention), adverse effects, acceptability of the procedure based on patient questionnaires, reasons for surgical intervention and adverse outcomes compared among the study groups.

Overall analysis of acceptability in these studies showed that nearly 97% of the Indian women found the medical methods highly acceptable, but most (86%) opted for hospital administration only, 6% for home administration and the remaining were indecisive.

For medical methods of abortion to work successfully, women must feel committed to completing the regimen, and both women and providers must wait while therapy takes its course.

Table 5.2.1
WHO multicentre abortion studies with AIIMS participation

Project A05217 : Comparison of two routes (sublingual and vaginal) and two intervals of Misoprostol for termination of early pregnancy

Project A15065 : A double blind randomised comparison of two misoprostol-regimens (sublingual and vaginal) in termination of pregnancy in the second trimester

Project A15066 : Pretreatment with misoprostol before vacuum aspiration for first trimester induced abortion : a multicentre double blind randomized controlled trial

Project A15078 : Comparison of two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a multinational randomized controlled trial

Project A25026 : Incidence and risk factors for Pelvic Inflammatory disease (PID) following induced abortion : a multicentre nested case control studies

NEW PROJECTS IN PIPELINE

Project A25121 : Comparison of medical and surgical methods to evacuate the uterus in women with a non-viable pregnancy up to 12 weeks of gestation : a randomized multicentre trial

Project A35148 : Comparison of four different misoprostol regimens after pre treatment with mifepristone for early pregnancy termination

 
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Introduction | Overview of the Consortium
Current Status of Medical Abortion | Consensus Issues & Recommendations
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