Complications of unsafe abortions are a major public health issue facing women of reproductive age in developing countries like India. Inducedabortions have been practised to varying degrees in all cultures by women facing unwanted pregnancies as a result of high level of unmet need for good quality family planning services. Safe, effective and affordable technologies to prevent unwanted pregnancies and to treat complications of abortions do exist, yet a large number of women in need are still deprived of the benefit of these technologies.

In India, an estimated 453 women die due to maternal causes for every 100,000 live births (UNFPA 1997). An average of 12 to 18% of maternal deaths result from unsafe abortion practices (Registrar General of India, 1996). Each abortion-related mortality represents manifold morbidity ranging from incomplete abortion, haemorrhage, cervical injury, uterine perforation, pelvic infection and infertility.

Indian Council of Medical Research (ICMR) has a network of Human Reproduction Research Centres(HRRCs), created with the objectives to undertake clinical trials of new technologies, to carry out programme introduction studies with new technologies and to undertake operational research for improving health-care delivery and utilisation of RCH services

Studies conducted on medical methods of termination of early pregnancy by ICMR are as follows:

(1) Phase II clinical trial with RU-486 alone or in combination with oral 9-methylene–PGE2 (meteneprost) for termination of early pregnancy within 49 days of amenorrhoea. (1987 - 89) (unpublished). The success rate ranged between 47% – 69% with four different treatment regimens. The data suggests that the addition of 9-methylene-PGE2 administered in the present form, orally does not increase the success rate.

(2) A multicentric clinical trial with RU-486 followed by 9-methylene PGE2 vaginal gel for termination of early pregnancy: Dose-finding study (1990-92) (Contraception 1994; 49: 87-98). A dose finding study was carried out with two different doses of RU486 (200 mg or 600 mg) each in combination with two different doses of 9-methylene-PGE2 vaginal gel (3mg or 5 mg) for termination of pregnancy between 7 and 28 days after missed menstrual period. It was observed that success rates with 200 mg RU486 followed by 3 mg and 5 mg 9- methylene-PGE2 vaginal gel were 94.5% and 89.6% in women with 7 to 14 days and 15 to 28 days of missed menstrual period respectively. These rates were similar to those observed with 600 mg RU486 given along with 3 mg or 5 mg or 9- methylene-PGE2 vaginal gel and were significantly higher than those observed with 200 mg RU486 given along with 3 mg 9-methylene-PGE2 vaginal gel. The average duration of bleeding in subjectswith complete abortion ranged between 7 and 11.8 days in 4 different schedules. There were no serious side-effects with any of the treatment schedules; only one subject required transfusion of one unit of blood for heavy bleeding. The immediate and delayed complication rates were similar with the four treatment schedules.

(3) A multicentric randomised comparative clinical trial of 200 mg RU-486 (mifepristone) single dose followed by either 5 mg 9-methylene PGE2 gel (meteneprost) or 600 µg oral PGE1 (misoprostol) for termination of early pregnancy within 28 days of missed menstrual period (1996). The study enrolled 907 women in 10 HRRCs, of these 9 were excluded due to protocol violations and 5 were lost to followup. The results of 893 subjects indicated a succes rate of 84.6% among 453 women treated with RU 486 and meteneprost that was not significantly different from the success rate of 87.7% observed in 440 women treated with RU486 and oral misoprostol. Most (90%) women started bleeding within 72 hours and about 26% even before the administration of any prostaglandin. Expulsion was reported in 7% of women before prostaglandin administration. There was no statistically significant difference between the two groups. The average duration of bleeding in all subjects was about 7 days. No life threatening side-effects were observed. Gastrointestinal side-effects were reported more often by women treated with oral PGE1 as compared to 9-methylene-PGE2 gel. Six subjects in each of the treatment groups required intravenous infusion of glucose and saline. Blood transfusion was required in 2 subjects, one in each treatment group, for profuse bleeding. (Contraception 2000; 62: 125-30)

(4) ICMR along with MOHFW has also started a study in 20 district hospitals to study the acceptability, efficacy and logistic requirement for medical method of termination of pregnancy in the existing clinical setting.To conclude, RU-486 (200 mg) orally followed by 600 µg of oral misoprostol for termination of early pregnancy is a better option because of ease of treatment administration. Back-up facilities for surgical evacuation and blood transfusion are essential.

Criteria for assessing the treatment outcomes for medical abortion :

Assessment of outcome is done on day 15 of RU- 486 administration.

The outcome is considered successful when the criteria fulfilled are: history of onset of bleeding per vaginum, history of expulsion of products/clots, decrease of uterine size to non-pregnant level, negative urine pregnancy test and no additional intervention required to complete the process of pregnancy termination.

Unsuccessful Outcome

Incomplete abortion: The outcome of treatment is considered as incomplete abortion in subjects who start bleeding but their uterine size remains bulky, on followup, irrespective of the fact whether the urine pregnancy test is positive or negative, or if additional surgical intervention is required to complete the process of evacuation of the products of conception.

Continuation of pregnancy : The outcome of treatment is considered as continuation of pregnancy if the uterine size increases from pretreatment condition and urine pregnancy test remains positive at follow-up even though vaginal bleeding may or may not have occurred.

Trial interruption : The outcome of treatment is also considered as unsuccessful when pregnancy has to be interrupted surgically before follow-up either due to medical reasons such as profuse bleeding or symptoms like severe abdominal pain or due to any other reason.