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

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ClinicalTrials.gov Identifier: NCT00325026
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
Premature Birth Cervical Ripening Drug: Misoprostol Device: Foley bulb Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
Study Start Date : April 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Primary Outcome Measures :
  1. Time to vaginal delivery

Secondary Outcome Measures :
  1. Rate of chorioamnionitis
  2. Incidence of abnormal fetal heart rate tracings
  3. Rate of postpartum hemorrhage
  4. Incidence of NICU admissions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325026

United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Keri a Baacke, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00325026     History of Changes
Other Study ID Numbers: 594-2004
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012

Keywords provided by University of Florida:
Preterm gestation
Cervical ripening
Labor induction
Foley bulb

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents