NCT Number: NCT02273115
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
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.
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Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Primary location
Christiana Care Health Services, Newark, Delaware, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Transcervical Foley Catheter
DeviceOther names: Transcervical Foley balloon
Primary outcomes
-
Delivery Rate
Time frame: Within 24 hours
The rate of women who deliver in less than or equal to 24 hours from Foley placement.
Secondary outcomes
-
Number of Participants With Time to Delivery Achieved Within 12 Hours
Time frame: Within 12 hours
Number of participants with a time from Foley placement to delivery less than or equal to 12 hours
-
Total Time to Delivery
Time frame: On average, 24-36 hours
-
Time to Foley Expulsion
Time frame: 0-12 hours
-
Number of Vaginal Deliveries
Time frame: Assessed after delivery, on average occurring between 24-48 hours
-
Regional Analgesia
Time frame: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
Regional analgesia used during Foley ripening
-
Obstetric Complications
Time frame: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
-
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7
Time frame: Assessed from birth through discharge, on average 2 days after birth
-
Neonatal Outcome: Neonatal Weight
Time frame: Assessed from birth through discharge, on average 2 days after birth
Sponsors and collaborators
Lead sponsor
Christiana Care Health Services
Other
Collaborators
- Thomas Jefferson University
Registry information
Official study title
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
Acronym: NOFOX
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Oct 23, 2014
- Registry last updated
- Jul 2, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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