A Randomized, Control Trial for Preinduction Cervical Ripening

NCT ID: NCT00393731

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Misoprostol

Intervention Type DRUG

oxytocin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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The University of Texas Health Science Center, Houston

Principal Investigators

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Michael Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Lyndon B. Johnson Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-04-008

Identifier Type: -

Identifier Source: org_study_id

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