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Combined Agent Randomized Trial of Induction of Labor

NCT ID: NCT00504465

Last Updated: 2007-07-20

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

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-04-30

Brief Summary

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To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

Detailed Description

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This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: \>36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score \<6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery \<24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.

Conditions

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Labor Induction Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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dinoprostone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \> or = to 36 weeks of gestation
* Singleton fetus
* Cephalic presentation
* Intact membranes and an unripe cervix (Bishop score \<6)

Exclusion Criteria

* Multifetal gestation
* Rupture of membranes
* Ripe cervix (Bishop score \>6)
* Active labor
* Contraindication to vaginal delivery
* Previous uterine surgery
* Non-cephalic presentation
* Fetal macrosomia
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Principal Investigators

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Daniel W Skupski, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Michael Cabbad, MD

Role: PRINCIPAL_INVESTIGATOR

The Brooklyn Hospital Center

Locations

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The Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status

New York Hospital Medical Center of Queens

Flushing, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0402-264

Identifier Type: -

Identifier Source: org_study_id