Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

This study is currently recruiting participants.

Verified by University of Florida, March 2006

First Received: May 10, 2006 No Changes Posted

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00325026

Purpose

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Condition	Intervention	Phase
Premature Birth Cervical Ripening	Drug: Misoprostol Device: Foley bulb	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Time to vaginal delivery

Secondary Outcome Measures:

Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage
Incidence of NICU admissions

Estimated Enrollment:	120
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2007

Detailed Description:

Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

singleton gestation, gestational age 23-35 weeks, indication for induction

Exclusion Criteria:

multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325026

Contacts

Contact: Keri A Baacke, MD	352-392-4254	baackek@obgyn.ufl.edu
Contact: Rodney K Edwards, MD, MS	352-392-4066	edwardsr@obgyn.ufl.edu

Locations

United States, Florida
Shands Hospital at the University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Keri A Baacke, MD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Keri a Baacke, MD

University of Florida

More Information

No publications provided

Study ID Numbers:	594-2004
Study First Received:	May 10, 2006
Last Updated:	May 10, 2006
ClinicalTrials.gov Identifier:	NCT00325026 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

Preterm gestation
Cervical ripening
Labor induction
Misoprostol
Foley bulb

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Misoprostol
Obstetric Labor Complications
Premature Birth

Additional relevant MeSH terms:

Pregnancy Complications
Oxytocics
Obstetric Labor, Premature
Misoprostol
Physiological Effects of Drugs
Obstetric Labor Complications
Gastrointestinal Agents

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents
Premature Birth

ClinicalTrials.gov processed this record on September 01, 2009