A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Delivery rate (proportion)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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
- •hepatitis B or C
- •unexplained vaginal bleeding
- •low-lying placenta
- •abnormal cervical anatomy or cervical cerclage
- •latex allergy
Outcomes
Primary Outcomes
Delivery rate (proportion)
Time Frame: Within 24 hours
Secondary Outcomes
- vaginal delivery rate(within 24 hours)
- use of anesthesia/analgesia(during induction and labor)
- overall complication rate (composite)
- duration of induction and labor