NCT02273115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

October 20, 2014

Results QC Date

March 17, 2017

Last Update Submit

June 2, 2017

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Keywords

inductionFoley catheteroxytocin

Outcome Measures

Primary Outcomes (1)

  • Delivery Rate

    The rate of women who deliver in less than or equal to 24 hours from Foley placement.

    Within 24 hours

Secondary Outcomes (8)

  • Number of Participants With Time to Delivery Achieved Within 12 Hours

    Within 12 hours

  • Total Time to Delivery

    On average, 24-36 hours

  • Time to Foley Expulsion

    0-12 hours

  • Number of Vaginal Deliveries

    Assessed after delivery, on average occurring between 24-48 hours

  • Regional Analgesia

    Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours

  • +3 more secondary outcomes

Study Arms (4)

Nulliparous - Foley only

ACTIVE COMPARATOR

Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.

Device: Transcervical Foley catheter

Nulliparous - Foley and oxytocin

ACTIVE COMPARATOR

Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.

Drug: OxytocinDevice: Transcervical Foley catheter

Multi(primi)parous - Foley only

ACTIVE COMPARATOR

Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.

Device: Transcervical Foley catheter

Multi(primi)parous - Foley and oxytocin

ACTIVE COMPARATOR

Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.

Drug: OxytocinDevice: Transcervical Foley catheter

Interventions

OxytocinDRUG
Multi(primi)parous - Foley and oxytocinNulliparous - Foley and oxytocin
Transcervical Foley catheterDEVICE
Also known as: Transcervical Foley balloon
Multi(primi)parous - Foley and oxytocinMulti(primi)parous - Foley onlyNulliparous - Foley and oxytocinNulliparous - Foley only

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • Pregnant, singleton gestation, vertex presentation
  • Admitted for induction of labor between gestational ages 24 - 42 weeks
  • Bishop score \<6

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (12)

  • 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.

    PMID: 14704239BACKGROUND

  • 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.

    PMID: 23303106BACKGROUND

  • 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.

    PMID: 21272849BACKGROUND

  • 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.

    PMID: 20502296BACKGROUND

  • 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.

    PMID: 21793769BACKGROUND

  • 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.

    PMID: 19232606BACKGROUND

  • 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.

    PMID: 15547534BACKGROUND

  • 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.

    PMID: 20636243BACKGROUND

  • 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.

    PMID: 18515515BACKGROUND

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

  • 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.

    PMID: 33757937DERIVED

  • 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.

    PMID: 28486381DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Corina Schoen
Organization
University of Massachusetts - Baystate
Corina.SchoenMD@baystatehealth.org
4137543470

Study Officials

  • Corina Schoen, MD

    Sidney Kimmel Medical College at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maternal Fetal Medicine Fellow

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 23, 2014

Study Start

October 1, 2014

Primary Completion

September 11, 2016

Study Completion

September 11, 2016

Last Updated

July 2, 2017

Results First Posted

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)