Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

Phase 4

Terminated

• Conditions: Vaginal Delivery; Cesarean Section
• Interventions: Drug: Dinoprostone; Drug: Oxytocin

• Registration Number: NCT01190163
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• Singleton pregnancy
• Gestational age ≥ 38 weeks
• Fetal cephalic presentation
• Bishop score < 6

Exclusion Criteria

• No uterine scar (no previous delivery by caesarean section)
• No more than 3 previous vaginal births
• No condition that disallows use of prostaglandins for induction of labor
• Premature rupture of the membranes
• Oligohydramnios

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Dinoprostone	-
B	Oxytocin	-

Primary Outcome Measures

Name	Time	Method
Vaginal birth delivery within 24 hours and C-section rate	24 hours

Secondary Outcome Measures

Name	Time	Method
Treatment failure rate	24 hours
Uterine hyperstimulation and/or fetal distress	24 hours
Use of additional oxytocin	24 hours

Trial Locations

Locations (4)

Hospital Maternidade Leonor Mendes de Barros; 🇧🇷 São Paulo, Brazil

Hospital M Boi Mirim; 🇧🇷 São Paulo, Brazil

Hospital Municipal Universitário - Faculdade de Medicina do ABC; 🇧🇷 São Bernardo, São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil