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Clinical Trials/NCT00393731
NCT00393731
Completed
Phase 2

A Randomized, Control Trial for Preinduction Cervical Ripening

The University of Texas Health Science Center, Houston1 site in 1 country540 target enrollmentJanuary 2004

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Labor, Induced
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
540
Locations
1
Primary Endpoint
Vaginal Delivery rates
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
August 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Vaginal Delivery rates

Secondary Outcomes

  • Time interval to delivery

Study Sites (1)

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