Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
Contact: | Corina Schoen, MD |
Email: | corina.schoen@jefferson.edu |
Phone: | 215-955-9200 |
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
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.
induction of labor will increase the rate of delivery within 24 hours stratified by parity.
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. Patients who receive prenatal care at Christiana Care may be
approached if an induction of labor is scheduled and consented at their prenatal visit. All
indications for induction will be included except those specifically mentioned as exclusion
criteria. Any contraindication for vaginal delivery would exclude the subject. After
informed consent is obtained, the Foley catheter will be placed and the subject will be
randomized to receive oxytocin (study group) or not (control group). After Foley catheter
removal or expulsion, the remainder of the induction course was left to the discretion of
the primary provider. Prior to randomization, the subject will be placed into the
nulliparous or multiparous group.
gestation between 24-42 weeks gestations presenting for labor induction will be offered
participation in this study. Patients who receive prenatal care at Christiana Care may be
approached if an induction of labor is scheduled and consented at their prenatal visit. All
indications for induction will be included except those specifically mentioned as exclusion
criteria. Any contraindication for vaginal delivery would exclude the subject. After
informed consent is obtained, the Foley catheter will be placed and the subject will be
randomized to receive oxytocin (study group) or not (control group). After Foley catheter
removal or expulsion, the remainder of the induction course was left to the discretion of
the primary provider. Prior to randomization, the subject will be placed into the
nulliparous or multiparous group.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
2
sites
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111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-9200
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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