Foley Catheter Versus Cervidil for Induction of Labor at Term

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Monique Lin, Obstetrix Medical Group

ClinicalTrials.gov Identifier:

NCT01402050

First received: April 8, 2011

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Purpose

OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction.

HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).

Condition	Intervention
Labor Induction	Drug: CERVIDIL (Dinoprostone) Device: FOLEY BALLOON

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women

Resource links provided by NLM:

Drug Information available for: Dinoprostone

U.S. FDA Resources

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:

Time Of Start Of Induction Of Labor To Delivery [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	June 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: FOLEY BALLOON Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery	Device: FOLEY BALLOON INDUCTION OF LABOR
Active Comparator: CERVIDIL	Drug: CERVIDIL (Dinoprostone) INDUCTION OF LABOR

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Eligibility

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

Criteria

Inclusion Criteria:

Cervix < 3 cm dilated. If 2cm dilated, must be < 80% effaced.
Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
Singleton gestation
Cephalic presentation

Exclusion Criteria:

Regular uterine contractions (more frequent than every 5 minutes)
PROM
Prior transverse uterine incision or any obstetric contraindication to labor
Fever (defined as a temperature of 38°C or higher)
Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
Fetal death
Placenta previa
Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
Non-reassuring fetal heart rate pattern
HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402050

Locations

United States, Arizona
Banner Desert Medical Center
Mesa, Arizona, United States, 85210
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006

Sponsors and Collaborators

Obstetrix Medical Group

Investigators

Principal Investigator:

Monique G Lin, MD

Obstetrix Medical Group

More Information

No publications provided

Responsible Party:	Monique Lin, MD, Obstetrix Medical Group
ClinicalTrials.gov Identifier:	NCT01402050 History of Changes
Other Study ID Numbers:	01-10-0012
Study First Received:	April 8, 2011
Last Updated:	May 9, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:

Time from the start of the induction to delivery

Additional relevant MeSH terms:

Dinoprostone
Oxytocics
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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