A prospective comparative study of 3 different regimens involving mifepristone and oral/ vaginalmisoprostol combination in medical termination of pregnancy at less than 9 weeks gestation

Abstract

Background and Objectives: Medical abortion with a combination of mifepristone and a prostaglandin analogue (Misoprostol) is a well-established and adequately studied as an alternative to surgical abortion in early pregnancy for many years now but still no consensus has been reached regarding superiority of one route and dosage. This study is an attempt to compare efficacy in terms of rate of complete abortion, side effects and women’s perceptions of three mifepristone/misoprostol regimens and to study the effect of continued oral misoprostol for one week in medical termination of pregnancies of less than nine weeks gestation. Materials and Methods: Abortion seeking women of less than nine weeks period of gestation were included in this study and were divided into three groups: GROUP I also referred as O+O group, GROUP II the V+O group, and GROUP III referred as V ONLY group. This is an outpatient regimen requiring minimum three visits on day 1, 3 and 15. Initially, tablet mifepristone 200 mg was administered orally in all three groups on day 1. This was followed on day 3 by oral misoprostol 0.8 mg in group I and vaginal 0.8 mg misoprostol in group II & III. It was placebo controlled. Patients were sent home after 4 hour observation period. The oral group and one of the vaginal groups i.e. group I and II continued 0.4 mg of oral misoprostol twice daily for 7 days. Final assessment was done on day 15. Results: All three groups were comparable in terms of rates of complete abortion: Group I 93.06%; II 94.44% and group III 93.06%. Incomplete abortion occurred in 9.72% women in group I, 5.52% in group II and 6.94% women in group III. 73.61 % of women in group I, 76.38% women in group II and 77.76% in group III suffered from lower abdominal pain & cramping. 100% women cited oral route as their preferred route and overall 199 (92%) women were satisfied with treatment, 12(5.6%) were unsure and 5(2.4%) were dissatisfied. For future purposes 100 % women cited medical abortion to be their preferred mode compared to surgical one Conclusion: In light of previous studies establishing superiority of vaginal route over oral, continuation of misoprostol for 7 days possibly improved the efficacy for oral misoprostol group(group I) but it did not seem to further increase the efficacy for vaginal Misoprostol (group II) as all three groups were of comparable efficacy. Additional misoprostol did not shorten the duration of bleeding or induction abortion interval compared to group not continuing additional one week misoprostol. Successful abortion was associated more with lower gestational age,multigravidas and multiparas.Oral group had higher frequency of nausea, vomiting and diarrhea than vaginal administration. Statistically insignificant but still lower number of women were satisfied in the end with the treatment in the oral group compared to vaginal groups despite oral mode being the preferred mode. Additional larger studies are required on initial oral misoprostol administration and its continuation to establish its equivalence to vaginal route.