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

Phase 4

Completed

• Conditions: Obstetric Labor; Cervical Ripening; Pregnancy; Induced Labor
• Interventions: Drug: Dinoprostone 10mg; Drug: Misoprostol 25 mcg

• Registration Number: NCT03744364
• Lead Sponsor: Hospital Miguel Servet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-10-20
• Study Completion: 2017-11-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-15
• Last Update Submitted: 2018-11-15
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dinoprostone	Dinoprostone 10mg	Group of women allocated to dinoprostone induction.
Misoprostol	Misoprostol 25 mcg	Group of women allocated to misoprostol induction.

Primary Outcome Measures

Name	Time	Method
Successful vaginal delivery within 24 hours	24 hours since induction was started	Percentage of women that achieve a vaginal delivery within 24 hours since induction process started

Secondary Outcome Measures

Name	Time	Method
Need for a second induction	Assessed 24 hours since induction of labor was started	Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
Vaginal delivery rate	Since labor induction had started until delivery had ocurred within 72 hours	Percentage of women that achieve vaginal delivery
Successful cervical ripening within 24 hours	24 hours since induction was started	Percentage of women that achieve Bishop score \> 6 within 24 hours since induction process started
Interval time from induction to delivery	Hours passed between induction of labor until delivery within 72 hours	Time passed since induction of labor started until delivery