Combined Agent Randomized Trial of Induction of Labor - Full Text View

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00504465

Purpose

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.

Condition	Intervention
Labor Induction Cervical Ripening	Drug: dinoprostone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Oxytocin Dinoprostone

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Rate of vaginal delivery <24 hours

Secondary Outcome Measures:

Randomization to delivery interval
Rate of cesarean delivery for non reassuring fetal status
Rate of uterine hyperstimulation

Estimated Enrollment:	210
Study Start Date:	May 2002
Study Completion Date:	April 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504465

Locations

United States, New York
The Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
New York Hospital Medical Center of Queens
Flushing, New York, United States, 11355
Weill Medical College of Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:	Daniel W Skupski, MD	Weill Medical College of Cornell University
Principal Investigator:	Michael Cabbad, MD	The Brooklyn Hospital Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00504465 History of Changes
Other Study ID Numbers:	0402-264
Study First Received:	July 19, 2007
Last Updated:	July 19, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Labor
Labor induction
Cervical ripening
Dinoprostone

Fetal safety
Oxytocin
Cesarean delivery

Additional relevant MeSH terms:

Dinoprostone
Oxytocics
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012