Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

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: NCT00468520
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : March 2, 2011
Information provided by:
Columbia University

Brief Summary:
The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

Condition or disease Intervention/treatment Phase
Pregnancy Induced Labor Cervical Ripening Drug: low dose oxytocin Not Applicable

Detailed Description:
This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
Study Start Date : November 2003
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Primary Outcome Measures :
  1. Delivery rate (proportion) [ Time Frame: Within 24 hours ]

Secondary Outcome Measures :
  1. vaginal delivery rate [ Time Frame: within 24 hours ]
  2. use of anesthesia/analgesia [ Time Frame: during induction and labor ]
  3. overall complication rate (composite)
  4. duration of induction and labor

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • singleton gestation
  • presenting for induction as determined by their primary obstetrical provider
  • with fetuses in cephalic presentation
  • gestational age greater than 23 weeks

Exclusion Criteria:

  • any condition precluding vaginal delivery
  • estimated fetal weight >4500 grams
  • a previous attempt at ripening or induction during the pregnancy
  • clinically significant cervical or vaginal infection
  • chorioamnionitis
  • HIV
  • hepatitis B or C
  • unexplained vaginal bleeding
  • low-lying placenta
  • abnormal cervical anatomy or cervical cerclage
  • latex allergy

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): NCT00468520

United States, New York
Columbia University Medical Center
New York, New York, United States, 10068
Sponsors and Collaborators
Columbia University
Principal Investigator: Patricia C Devine, MD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00468520     History of Changes
Other Study ID Numbers: WIRB 20030859
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: February 2011

Keywords provided by Columbia University:
induction of labor
cervical ripening
Foley catheter

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