[New formulation of sublingual misoprostol (25 mcg) for induction of labor]

Abstract

Objectives: To determine effectiveness and safety of sublingual misoprostol in tablets of 25 mcg, given every 6 hours for induction of labor in high-risk pregnant women hospitalized in two teaching hospitals in the Northeast of Brazil.

Methods: An open, non-randomized clinical trial was conducted, including 40 women with high-risk pregnancies hospitalized at "Maternidade-Escola Assis Chateaubriand" and "Instituto Materno-Infantil de Pernambuco". All of them had gestational age >or= 37 weeks, alive fetus with good vitality and Bishop scores <or= 7. A tablet of 25 mcg of misoprostol was administered every 6 hours, up to a maximum of 4, until active labor. Statistical analysis was performed using the public domain software Epi-Info 3.2.2.

Results: Active labor occurred in 100% of cases after misoprostol administration. The mean (+/-SD) induction-to-labor interval was 4.8(+/-3.8 hours. Interval from induction-to-delivery varied from 8 to 31 hours with 95% of the deliveries occurring in the first 24 hours with 75% of vaginal deliveries. The frequency of tachysystole was 12.5%. The women did not present relevant side effects neither were there any neonatal complications.

Conclusions: The sublingual tablet of misoprostol of 25 mcg was shown to be effective for induction of labor in high-risk pregnant women. The efficacy and acceptability of this new route should be compared to vaginal administration of misoprostol in future prospective randomized clinical trials.