A Randomized, Control Trial for Preinduction Cervical Ripening

Phase 2

Completed

• Conditions: Labor, Induced

• Registration Number: NCT00393731
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-29
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

• Women that are hospitalized for induction of labor that have a Bishop's score <5
• singleton gestation
• cephalic presentation
• 24 weeks gestational age

Exclusion Criteria

• Prior uterine surgery
• malpresentation
• placenta previa or abruption
• clinically suspected or diagnosed intra amniotic infection
• genital HSV infection
• multiple gestation
• premature rupture of the membranes
• active labor
• maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vaginal Delivery rates

Secondary Outcome Measures

Name	Time	Method
Time interval to delivery

Trial Locations

Locations (1)

Lyndon B. Johnson Hospital; 🇺🇸 Houston, Texas, United States