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

Not Applicable

Completed

• Conditions: Pregnancy; Induced Labor; Cervical Ripening

• Registration Number: NCT00468520
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-11
• Study Completion: 2005-10
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-28
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Delivery rate (proportion)	Within 24 hours

Secondary Outcome Measures

Name	Time	Method
vaginal delivery rate	within 24 hours
use of anesthesia/analgesia	during induction and labor
overall complication rate (composite)
duration of induction and labor

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States