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

Pregnancy Clinical Trial

Official title:

A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468520
• Other study ID #: WIRB 20030859
• Status: Completed
• Phase: N/A
• First received: May 1, 2007
• Last updated: February 28, 2011
• Start date: November 2003
• Est. completion date: October 2005

Study information

• Verified date: February 2011
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Induced Labor
• Pregnancy

Intervention

Drug:
• low dose oxytocin

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery rate (proportion)		Within 24 hours
Secondary	vaginal delivery rate		within 24 hours
Secondary	use of anesthesia/analgesia		during induction and labor
Secondary	overall complication rate (composite)
Secondary	duration of induction and labor