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Foley Catheter Versus Cervidil for Induction of Labor at Term

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402050
First Posted: July 26, 2011
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mednax Center for Research, Education and Quality
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Mednax Center for Research, Education and Quality:

Primary Outcome Measures:
  • Time Of Start Of Induction Of Labor To Delivery [ Time Frame: 2 Years ]

Enrollment: 330
Study Start Date: June 2010
Study Completion Date: February 2015
Primary Completion Date: November 2014 (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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Regular uterine contractions (more frequent than every 5 minutes)
  2. PROM
  3. Prior transverse uterine incision or any obstetric contraindication to labor
  4. Fever (defined as a temperature of 38°C or higher)
  5. Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
  6. Fetal death
  7. Placenta previa
  8. Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
  9. Non-reassuring fetal heart rate pattern
  10. HIV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Mednax Center for Research, Education and Quality
Investigators
Principal Investigator: Monique G Lin, MD Obstetrix Medical Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier: NCT01402050     History of Changes
Other Study ID Numbers: 01-10-0012
First Submitted: April 8, 2011
First Posted: July 26, 2011
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mednax Center for Research, Education and Quality:
Time from the start of the induction to delivery

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs