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

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00468520
First received: May 1, 2007
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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 Intervention
Pregnancy
Induced Labor
Cervical Ripening
Drug: low dose oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening

Resource links provided by NLM:


Further study details as provided by Columbia University:

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

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

Enrollment: 200
Study Start Date: November 2003
Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468520

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

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00468520     History of Changes
Other Study ID Numbers: WIRB 20030859
Study First Received: May 1, 2007
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014