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NCT00325026 Clinical Trial

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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00325026
Other study ID # 594-2004
Secondary ID
Status Completed
Phase Phase 2
First received May 10, 2006
Last updated March 1, 2012
Start date April 2005
Est. completion date April 2007

Study information
Verified date March 2012
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol

Device:
• Foley bulb

Locations
Country Name City State
United States Shands Hospital at the University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to vaginal delivery
Secondary Rate of chorioamnionitis
Secondary Incidence of abnormal fetal heart rate tracings
Secondary Rate of postpartum hemorrhage
Secondary Incidence of NICU admissions
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