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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Miguel Servet
• Treatments: Dinoprostone; Misoprostol

Criteria

Inclusion Criteria:

• Singleton uncomplicated pregnancy

• Nulliparity

• Live fetus

• 286 days of gestational age or above

• Abscence of contraindication for vaginal delivery

• Bishop score lower than 6

Exclusion Criteria:

• Multiple pregnancy

• Multiparity

• Stillbirth

• Oligohydramnios

• Suspected fetal distress

• Severe asthma

• Intolerance/allergy to prostaglandins

• Contraindication for vaginal birth