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: January 22, 2014
Last verified: January 2014
  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:


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 2014
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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: January 22, 2014
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 April 23, 2014