A Randomized, Control Trial for Preinduction Cervical Ripening

This study has been completed.

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00393731

Purpose

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.

Condition	Intervention	Phase
Labor, Induced	Drug: Misoprostol Drug: oxytocin	Phase II

Drug Information available for: Oxytocin Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Control Trial for Preinduction Cervical Ripening

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Vaginal Delivery rates

Secondary Outcome Measures:

Time interval to delivery

Estimated Enrollment:	540
Study Start Date:	January 2004
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:

Female

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393731

Locations

United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77026

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Michael Lucas, MD

The University of Texas Health Science Center, Houston

More Information

Responsible Party:	The University of Texas Health Science Center, Houston ( Michael Lucas, M.D. )
Study ID Numbers:	HSC-MS-04-008
Study First Received:	October 26, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00393731
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

labor
induction
misoprostol
oxytocin

Study placed in the following topic categories:

Misoprostol
Oxytocin

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Physiological Effects of Drugs

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009