Ensayo clínico aleatorizado sobre la vía de administración más segura del Misoprostol para maduración cervical e inducción de embarazos a término

Abstract

OBJECTIVE: To identify the most effective misoprostol’s route of administration with less collateral effects to reach cervical ripening and labor induction of full-term pregnant patients with obstetric indication of termination of pregnancy by vaginal delivery. METHODS: This is a randomized controlled clinical trial performed at “Vicente Corral Moscoso” hospital. The study sample was composed of 80 randomized patients with obstetric indication of termination of pregnancy by vaginal delivery, they were assigned in two groups (sublingual and vaginal administration routes); misoprostol dosage was 25ug per each administering. Patients were examined with vaginal tactus which was performed every 4 hours to determine cervical ripening (Bishop’s index). Cervical ripening, uterine activity, route of administration, pregnancy termination route, number of doses administered, collateral effects and APGAR’s newborn data were registered in an autor’s questionnaire. Study groups were compared and data were analyzed by descriptive statistics, squared chi and relative risk with a 95% confidence interval. RESULTS: Groups were similares, except by gestational age and induction cause (p ˂ 0.05). Sublingual route demonstrated a lower requirement of doses in those patients who had a vaginal birth (RR: 1.28; CI 95%: 1.002 – 1.642; p < 0.05), there were no differences in cervical ripening, uterine activity, adverse effects and APGAR’s of newborns. CONCLUSIONS: Misoprostol is an effective drug for labor induction and cervical ripening regardless to administration route, those patients who had a vaginal delivery required less number of sublingual route doses to produce the expected effect.