A pilot randomised study to compare sub-lingual and vaginal routes of low-dose misoprostol following two sequential doses of mifepristone for second-trimester medical abortion.

Abstract

Primary objective: A randomized study to compare the induction abortion interval (IAI) using two different routes of Low-dose misoprostol administration Sublingual (S/L) and vaginal, after priming with two sequential doses of mifepristone for second-trimester medical abortion.

Study design: After randomization in two groups, participants received two doses of mifepristone (200 mg) 24 h apart. On day 3, 200mcg of misoprostol was given by S/L route to group 1 and by vaginal route to group 2, (400mcg among women with gestation ≤16 weeks) and every 6 hours for a maximum of 3 doses.

Results: The mean IAI (13.71±8.55 h and 13.22±8.22 h; p=0.768), mean number of misoprostol doses (2.08±1.08 and 2.54±1.12, p=0.05) and mean misoprostol dose (453.9±224.93 and 492.31±208.23 mcg, p=0.409) was similar. The complete abortion rate after 24 h (77.5% vs 87.5%, p=0.23), after 48 h (95% vs 97.5%, p=1.00) and minimal untoward effects seen were all similar in the two groups.

Conclusions: Both SL and vaginal routes of misoprostol, after two doses of mifepristone were equally effective. The mean cumulative doses of misoprostol were similar, and a complete abortion rate of > 95% at 48 h was achieved with either route.$>95$.