Clinical trial NCT02273115: Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Official title: Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Keywords: induction
Foley catheter
oxytocin
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2014-10-23
Enrollment: 323
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery Rate
timeFrame: Within 24 hours
Secondary outcomes:
measure: Number of Participants With Time to Delivery Achieved Within 12 Hours
timeFrame: Within 12 hours
measure: Total Time to Delivery
timeFrame: On average, 24-36 hours
measure: Time to Foley Expulsion
timeFrame: 0-12 hours
measure: Number of Vaginal Deliveries
timeFrame: Assessed after delivery, on average occurring between 24-48 hours
measure: Regional Analgesia
timeFrame: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
measure: Obstetric Complications
timeFrame: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
measure: Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7
timeFrame: Assessed from birth through discharge, on average 2 days after birth
measure: Neonatal Outcome: Neonatal Weight
timeFrame: Assessed from birth through discharge, on average 2 days after birth
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Medical College at Thomas Jefferson University
name: Corina Schoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical foley catheter and the risk of uterine rupture. Obstet Gynecol. 2004 Jan;103(1):18-23. doi: 10.1097/01.AOG.0000109148.23082.C1.
citation: Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
citation: Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.
citation: Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.
citation: Fitzpatrick CB, Grotegut CA, Bishop TS, Canzoneri BJ, Heine RP, Swamy GK. Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Jul;25(7):1006-10. doi: 10.3109/14767058.2011.607522. Epub 2011 Dec 14.
citation: Kashanian M, Nazemi M, Malakzadegan A. Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening. Int J Gynaecol Obstet. 2009 May;105(2):174-5. doi: 10.1016/j.ijgo.2009.01.005. Epub 2009 Feb 20. No abstract available.
citation: Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol. 2004 Nov;191(5):1632-6. doi: 10.1016/j.ajog.2004.03.033.
citation: Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
citation: Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
citation: Gagnon J, Corlin T, Berghella V, Hoffman MK, Sciscione A, Marie PS, Schoen CN. Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score </=3: a secondary analysis. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100350. doi: 10.1016/j.ajogmf.2021.100350. Epub 2021 Mar 20.
citation: Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.