BACKGROUND:Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration. AIMS: To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion. METHODS: A randomised comparative trial where 300 women at 13-20 weeks gestation, requiring medical abortion, were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of 400 microg three-hourly, up to a maximum five doses over 24 h. The same doses were repeated for another 24 h in non-responders. Primary outcome measure was complete abortion rate at 24 and 48 h, and the secondary outcome measures were induction-abortion interval, failure rate, side-effects and patients' preference to the route. RESULTS: No statistically significant differences in the complete abortion rates were observed at 24 h (64.03% vs 61.59%, P = 0.767) and at 48 h (79.14% vs 82.01%, P = 0.651) when sublingual and vaginal groups were compared. Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h, respectively (P = 0.066). Other outcome measures were also more or less similar in both groups. Differences in the incidence of side-effects were also statistically insignificant when both groups were compared. Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration (P < 0.0001). CONCLUSION: Both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients.
RCT Entities:
BACKGROUND:Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration. AIMS: To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion. METHODS: A randomised comparative trial where 300 women at 13-20 weeks gestation, requiring medical abortion, were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of 400 microg three-hourly, up to a maximum five doses over 24 h. The same doses were repeated for another 24 h in non-responders. Primary outcome measure was complete abortion rate at 24 and 48 h, and the secondary outcome measures were induction-abortion interval, failure rate, side-effects and patients' preference to the route. RESULTS: No statistically significant differences in the complete abortion rates were observed at 24 h (64.03% vs 61.59%, P = 0.767) and at 48 h (79.14% vs 82.01%, P = 0.651) when sublingual and vaginal groups were compared. Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h, respectively (P = 0.066). Other outcome measures were also more or less similar in both groups. Differences in the incidence of side-effects were also statistically insignificant when both groups were compared. Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration (P < 0.0001). CONCLUSION: Both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients.