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Completed

NCT Number: NCT00325026

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

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

Completed

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Key information

Conditions

Premature Birth Cervical Ripening Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Foley bulb

Device

Primary outcomes

  1. Time to vaginal delivery

Secondary outcomes

  1. Rate of chorioamnionitis

  2. Incidence of abnormal fetal heart rate tracings

  3. Rate of postpartum hemorrhage

  4. Incidence of NICU admissions

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
May 11, 2006
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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