Status:
COMPLETED
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
Labor; Forced or Induced, Affecting Fetus or Newborn
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.
Detailed Description
This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Pregnant, singleton gestation, vertex presentation
- Admitted for induction of labor between gestational ages 24 - 42 weeks
- Bishop score \<6
Exclusion
- Multiple gestation
- Non-vertex presentation
- Latex allergy or latex-free Foley catheter to be placed
- Fetal death
- Anomalous fetus
- Placenta/vasa previa
- Placental abruption (known or suspected)
- Intrapartum bleeding
- Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring \>50% of contractions
- 2 or more previous cesarean section, myomectomy, or classical cesarean
- Need to use ripening agents prior to Foley placement
- Spontaneous labor
- Active genital herpes
- Inability to consent
- Any contraindication to a vaginal delivery
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2016
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT02273115
Start Date
October 1 2014
End Date
September 11 2016
Last Update
July 2 2017
Active Locations (2)
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1
Christiana Care Health Services
Newark, Delaware, United States, 19713
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107