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

University of Florida130 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Premature Birth Cervical Ripening

Interventions

MisoprostolDRUG

Foley bulbDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Time to vaginal delivery

Secondary Outcomes

Rate of chorioamnionitis

Incidence of abnormal fetal heart rate tracings

Rate of postpartum hemorrhage

Incidence of NICU admissions

Data from ClinicalTrials.gov

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