Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Labor; Forced or Induced, Affecting Fetus or Newborn Clinical Trial

— NOFOX  

Official title:

Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273115
• Other study ID #: CCC-34107
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2014
• Last updated: September 8, 2016
• Start date: October 2014

Study information

• Verified date: September 2016
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institution Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention

Drug:
• Oxytocin

Device:
• Transcervical Foley catheter

Locations

Country	Name	City	State
United States	Christiana Care Health Services	Newark	Delaware
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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):247-52. doi: http://10.1097/AOG.0b013e31827e5dca. — View 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. — View 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):1239-45. doi: 10.1097/AOG.0b013e3181dec6d0. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery Rate (proportion)		Within 24 hours	No
Secondary	Time to delivery		Within 12 hours	No
Secondary	Total time to delivery		On average, 24-36 hours	No
Secondary	Time to foley expulsion		0-12 hours	No
Secondary	Number of vaginal deliveries		Assessed after delivery, on average occurring between 24-48 hours	No
Secondary	Analgesia use		Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours	No
Secondary	Obstetric complications: rupture of membranes with Foley in place, chorioamnionitis, postpartum hemorrhage, tachysystole, category 2/3 fetal tracing, Foley catheter breakage, uterine rupture, ICU admission and maternal death	We will collect data on obstetric complications that occur during the induction and delivery including: rupture of membranes with Foley in place, chorioamnionitis, postpartum hemorrhage, tachysystole, category 2/3 fetal tracing, Foley catheter breakage, uterine rupture, ICU admission and maternal death	Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period	No
Secondary	Neonatal outcome: weight, apgars, NICU (neonatal intensive care unit) admission and length of stay	Neonatal outcomes of weight, apgars, NICU (neonatal intensive care unit) admission and length of stay	Assessed from birth through discharge, on average 2 days after birth	No