Status:
COMPLETED
Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
Lead Sponsor:
Columbia University
Conditions:
Pregnancy
Induced Labor
Eligibility:
FEMALE
18-55 years
Phase:
NA
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 combinati...
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 plu...
Eligibility Criteria
Inclusion
- singleton gestation
- presenting for induction as determined by their primary obstetrical provider
- with fetuses in cephalic presentation
- gestational age greater than 23 weeks
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00468520
Start Date
November 1 2003
End Date
October 1 2005
Last Update
March 2 2011
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10068