Comparison or oral versus vaginal misoprostol & continued use of misoprostol after mifepristone for early medical abortion

Background & objectives: Medical abortion though legalized in India, is still not very popular. A disadvantage of medical abortion is the longer duration of bleeding compared with surgical abortion which may reduce acceptability. Due consideration needs to be given to the issues related to medical abortion for improving the reproductive health status of women suffering from consequences of unsafe and illegal surgical abortion. The present study compared the efficacy of oral and vaginal administration of misoprostol after a single dose of 200 mg of mifepristone and evaluated the influence of continuing misoprostol for one week on efficacy and side effects.

Methods: A double-blind randomized controlled trial with 150 healthy pregnant women requesting medical abortion with

Results: Complete abortion rate in each of the groups was 96-100 per cent. The addition of misoprostol 0.4 mg twice a day from day 4-10 did not help in increasing successful outcome or shortening of duration or amount of bleeding.

Interpretation & conclusion: Medical abortion for pregnancy up to 63 days using misoprostol 0.8 mg vaginal/oral after pretreatment with mifepristone 200 mg is a safe and successful procedure. No differences in efficacy or duration of bleeding were observed with addition of oral misoprostol for 1 wk after abortion.

Key words Abortifacient efficacy * duration of bleeding * medical abortion * misoprostol

In India, 6.7 million induced abortions are performed a year, with ratio of 452 abortions per 1000 live births or 60 induced abortions per 1000 women of child bearing age'. Although abortion was legalized in India in 1972, illegal abortion is still three (urban) to five (rural) times more common than legal abortion2. Medical abortion offers great potential for improving abortion access and safety, as it requires a less extensive infrastructure than surgical abortion.

Research has been continued to improve the medical abortion regimen since its inception. It has also been demonstrated that the oral misoprostol dose of 0.4 m g was insufficient when the length of pregnancy was more than seven weeks3,4. Studies have also shown that vaginal administration of misoprostol after pre-treatment with mifepristone resulted in higher complete abortion compared to oral dose5. A disadvantage of medical abortion is the longer duration of bleeding compared with surgical abortion which may reduce acceptability. The present study was planned to find a safe, simple and optimally effective regimen of mifepristone and misoprostol for abortion of pregnancy up to 63 days. Three different regimens were tested and abortifacient efficacy, side effects and the duration of bleeding of the three treatment regimens differing in the route of administration and in the duration of treatment with misoprostol were compared.

Material & Methods

The study has been carried out in the Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi, as a part of WHO multicentric, double-blind, randomized controlled trial from November 1998 to March 2000. The trial included 1 50 healthy pregnant women requesting legal termination of pregnancy up to 9 wk or

Computer generated random number sequence was used for randomization of women to one of the three groups. Mifepristone 200 mg orally was administered on day one of study. On day three (36-48 h later) the group 1 women (oral/oral) received 0.8 mg of misoprostol orally and placebo vaginally, group 2 (vaginal/oral) and group 3 (vaginal only) women received 0.8 mg of misoprostol vaginally and placebo tablets orally. After administration of misoprostol, women were observed for 3 h for pulse, temperature and blood pressure, and side effects and onset of bleeding recorded. Those in groups 1 and 2 received 0.4 m g misoprostol twice daily for seven days, starting on day four of study, while women in group 3 took placebo tablets. Pelvic examination was done at the end of 3 h observation. Participants were requested to maintain a diary card to record days of bleeding and occurrence of side effects. The subjects returned for follow up evaluations on days 15 and 43 after beginning the treatment. All had haemoglobin estimation, record of the diary card, pelvic examination and ultrasonography, if necessary. Double blinding was maintained throughout the study and drugs were provided by the World Health Organisation.

The three regimens were compared in their efficacy to induce complete abortion, frequency of side effects, and duration of bleeding. Complete abortion was confirmed by passage of products of conception and by clinical findings at pelvic examination and on curettage during the period up to the first menstruation. Missed abortion included a non-viable pregnancy on ultrasonography. Failure was a continuing pregnancy. Incomplete abortion included those requiring curettage for completion. Those women who had vacuum aspiration before the outcome was known and who were lost to follow up were classified as undetermined.