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Foley Catheter Versus Cervidil for Induction of Labor at Term

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. Identifier: NCT01402050
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : February 6, 2020
Last Update Posted : March 2, 2020
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Labor Induction Drug: CERVIDIL (Dinoprostone) Device: FOLEY BALLOON Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: FOLEY BALLOON
Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery

Active Comparator: CERVIDIL Drug: CERVIDIL (Dinoprostone)

Primary Outcome Measures :
  1. Time Of Start Of Induction Of Labor To Delivery [ Time Frame: Hours ]

    The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction.

    There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01402050

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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
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Principal Investigator: Monique G Lin, MD Obstetrix Medical Group
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pediatrix Identifier: NCT01402050    
Other Study ID Numbers: 01-10-0012
First Posted: July 26, 2011    Key Record Dates
Results First Posted: February 6, 2020
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pediatrix:
Time from the start of the induction to delivery
Additional relevant MeSH terms:
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Reproductive Control Agents
Physiological Effects of Drugs