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

This study has been completed.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
First received: May 10, 2006
Last updated: March 1, 2012
Last verified: March 2012
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Resource links provided by NLM:

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

Enrollment: 130
Study Start Date: April 2005
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.

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00325026     History of Changes
Other Study ID Numbers: 594-2004 
Study First Received: May 10, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 26, 2016