Open AccessLow‐dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial
Author(s) -
De Bonrostro Torralba Carlos,
Tejero Cabrejas Eva Lucía,
Envid Lázaro Blanca Mar,
Franco Royo Maria Jesús,
Roca Arquillué Montserrat,
Campillos Maza Jose Manuel
Publication year - 2019
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/aogs.13556
Subject(s) - medicine , dinoprostone , misoprostol , obstetrics , gestational age , apgar score , neonatal intensive care unit , randomized controlled trial , vaginal delivery , labor induction , randomization , prospective cohort study , gynecology , pregnancy , surgery , oxytocin , abortion , prostaglandin , pediatrics , biology , genetics
The aim of this study was to compare the efficacy and safety of a low‐dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post‐term pregnancies. Material and methods We designed a prospective, randomized, open‐labeled trial with evaluators blinded to the end‐point, including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and a Bishop score <6. They were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable. A P value <0.05 was considered statistically significant. This study was registered in ClinicalTrials.gov (number NTC 03744364). Results We included 198 women for analysis (99 women in each group). Vaginal birth rate within 24 hours did not differ between groups (49.5% vs 42.4%; P = 0.412). When the Bishop score was <4, dinoprostone insert showed a higher probability of vaginal delivery within 12 hours (17.8% vs 4%; P = 0.012). In the dinoprostone group, removal of the insert was more likely to be due to an adverse event (5.1% vs 14.1%; P = 0.051) and an abnormal fetal heart rate pattern during active labor (44.4% vs 58.6%; P = 0.047). Both groups were similar in neonatal outcomes including Apgar score, umbilical cord pH and neonatal intensive care unit admission. Conclusions Low‐dose vaginal misoprostol and vaginal dinoprostone insert seem to be equally effective and safe for induction of labor in pregnant women with a gestational age beyond 41 weeks.