Official Title: “A Randomized, Control Trial for Preinduction Cervical Ripening”

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
• Drug: oxytocin

Primary Measures

• Vaginal Delivery rates

Secondary Measures

• Time interval to delivery

Inclusion Criteria:

• Women that are hospitalized for induction of labor that have a Bishop's score <5
• singleton gestation
• cephalic presentation
• 24 weeks gestational age

Exclusion Criteria:

• Prior uterine surgery
• malpresentation
• placenta previa or abruption
• clinically suspected or diagnosed intra amniotic infection
• genital HSV infection
• multiple gestation
• premature rupture of the membranes
• active labor
• maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: The University of Texas Health Science Center, Houston

Overall Clinical Trial Officials and Contacts

Michael Lucas, MD Principal Investigator The University of Texas Health Science Center, Houston  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393731

Study ID Number: HSC-MS-04-008

ClinicalTrials.gov Identifier: NCT00393731

Health Authority: United States: Institutional Review Board