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

University of Florida

Status and phase: Completed; Phase 2

Conditions: Cervical Ripening; Premature Birth

Treatments: Device: Foley bulb; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00325026

594-2004

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)