A Randomized, Control Trial for Preinduction Cervical Ripening

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT00393731

Collaborator

(none)

540

Enrollment

Location

Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Labor, Induced	Drug: Misoprostol Drug: oxytocin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Randomized, Control Trial for Preinduction Cervical Ripening

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Vaginal Delivery rates []

Secondary Outcome Measures

Time interval to delivery []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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