A Randomized, Control Trial for Preinduction Cervical Ripening - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 26, 2006

Last Updated Date

January 11, 2008

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Vaginal Delivery rates

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00393731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Time interval to delivery

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Randomized, Control Trial for Preinduction Cervical Ripening

Official Title ^†

A Randomized, Control Trial for Preinduction Cervical Ripening

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Labor, Induced

Intervention ^†

Drug: Misoprostol
Drug: oxytocin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

540

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00393731

Responsible Party

Michael Lucas, M.D., The University of Texas Health Science Center, Houston

Secondary IDs ^††

Study Sponsor ^†

The University of Texas Health Science Center, Houston

Collaborators ^††

Investigators ^†

Principal Investigator:

Michael Lucas, MD

The University of Texas Health Science Center, Houston

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.