NCT03744364

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

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Hospital Miguel Servet · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Induced Labor
• Cervical Ripening
• Obstetric Labor
• Pregnancy

Interventions

Type	Name	Description
DRUG	Misoprostol 25 mcg	To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
DRUG	Dinoprostone 10mg	To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-10-20
• Completion: 2017-11-01
• First posted: 2018-11-16
• Last updated: 2018-11-16