Administration Of Misoprostol For Termination Research Articles

A randomised comparative study on sublingual versus vaginal administration of misoprostol for termination of pregnancy between 13 to 20 weeks

Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration. To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion. 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. 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). 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.

Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial

The most effective route and best interval between several doses of misoprostol to induce abortion have not been defined. Our aim was to assess the effects of the interval between multiple doses of misoprostol and the route of administration to terminate pregnancy. 2066 healthy pregnant women requesting medical abortion with 63 days or less of gestation were randomly assigned within 11 gynaecological centres in six countries to the four treatment groups (three doses of 0.8 mg misoprostol given sublingually at 3-h intervals, vaginally 3 h, sublingually 12 h, and vaginally 12 h), stratifying by gestational age. This was an equivalence trial with a 5% margin of equivalence. The primary endpoints were efficacy of treatment to achieve complete abortion and to terminate pregnancy. The main efficacy analysis excluded women lost to follow-up. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN10531821. Efficacy outcomes were analysed for 2046 women (99%), excluding 20 lost to follow-up. Complete abortion rates at 2-week follow-up were recorded for 431 (84%) in the sublingual and for 434 (85%) women in the vaginal group when misoprostol was given at 3-h intervals (difference 0.4%, 95% CI -4.0 to 4.9, p=0.85 equivalence shown), and for 399 (78%) in the sublingual and for 425 (83%) in the vaginal 12-h groups (4.6%, -0.2 to 9.5, p=0.06, equivalence not shown). In the 3-h groups, pregnancy continued in 29 (6%) women after sublingual and in 20 (4%) women after vaginal administration (difference 1.8%, 95% CI -0.8 to 4.4, p=0.19, equivalence shown); in the 12-h groups it continued in 47 (9%) after sublingual and in 25 (5%) after vaginal administration (4.4%, 1.2-7.5, p=0.01, vaginal better than sublingual). Differences for complete abortion between intervals for sublingual and vaginal routes were 6% (95% CI 1.0-10.6, p=0.02, 3 h better than 12 h) and 2% (-2.9 to 6.1, p=0.49, equivalence not shown), respectively; for continuing pregnancies they were 4% (0.4-6.8, p=0.03, 3 h better than 12 h) and 1% (-1.5 to 3.5, p=0.44, equivalence shown), respectively. Administration interval can be chosen between 3 h and 12 h when misoprostol is given vaginally. If administration is sublingual, the intervals between misoprostol doses need to be short, but side-effects are then increased. With 12-h intervals, vaginal route should be used, whereas with 3-h intervals either route could be chosen.