drugset / Trial / NCT03744364

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

NCT03744364

Phase 4 Completed 198 enrolled Hospital Miguel Servet
RandomizedParallel-groupSingle-blindTreatment

Summary

Purpose: To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies. Methods: The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants 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.

Timeline

Start
2014-06-01
Primary completion
2017-10-20
Completion
2017-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dinoprostone Other / unclassified 10 mg Other
Comparator Misoprostol Other / unclassified 25 ug Other