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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Short name NOFOX

NCTNCT02273115 (opens ClinicalTrials.gov in a new tab)Other idCCC-34107
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
323 participants (actual)
Sponsor
Christiana Care Health Services · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2014
Primary completion
11 Sept 2016
Completion
11 Sept 2016
First posted
23 Oct 2014 (estimated)
Last update posted
2 Jul 2017
Conditions
Labor; Forced or Induced, Affecting Fetus or Newborn

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 4

    NOFOX

    NCT02273115

    Oct 2014 to 11 Sept 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • Transcervical Foley catheterDevice

Arms4

  • Active comparator

    Nulliparous - Foley only

    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.

  • Active comparator

    Nulliparous - Foley and oxytocin

    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.

  • Active comparator

    Multi(primi)parous - Foley only

    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.

  • Active comparator

    Multi(primi)parous - Foley and oxytocin

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Delivery Rate

    Time frame · Within 24 hours

    Registry description

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

Secondary outcomes(8)

  1. Number of Participants With Time to Delivery Achieved Within 12 Hours

    Time frame · Within 12 hours

    Registry description

    Number of participants with a time from Foley placement to delivery less than or equal to 12 hours

  2. Total Time to Delivery

    Time frame · On average, 24-36 hours

  3. Time to Foley Expulsion

    Time frame · 0-12 hours

  4. Number of Vaginal Deliveries

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

  5. Regional Analgesia

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

    Registry description

    Regional analgesia used during Foley ripening

  6. Obstetric Complications

    Time frame · Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period

  7. 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

  8. Neonatal Outcome: Neonatal Weight

    Time frame · Assessed from birth through discharge, on average 2 days after birth

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Within 24 hours

Delivery Rate

GroupValue (Participants)
Nulliparous - Foley Only40
Nulliparous - Foley and Oxytocin58
Multi(Primi)Parous - Foley Only48
Multi(Primi)Parous - Foley and Oxytocin62
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Within 12 hours

Number of Participants With Time to Delivery Achieved Within 12 Hours

GroupValue (Participants)
Nulliparous - Foley Only2
Nulliparous - Foley and Oxytocin7
Multi(Primi)Parous - Foley Only13
Multi(Primi)Parous - Foley and Oxytocin23
Secondary outcomeMedian· On average, 24-36 hours

Total Time to Delivery

GroupValue (hours)
Nulliparous - Foley Only26.1
Nulliparous - Foley and Oxytocin20.9
Multi(Primi)Parous - Foley Only18.6
Multi(Primi)Parous - Foley and Oxytocin14.9
Secondary outcomeMedian· 0-12 hours

Time to Foley Expulsion

GroupValue (hours)
Nulliparous - Foley Only11.8
Nulliparous - Foley and Oxytocin7.2
Multi(Primi)Parous - Foley Only7.9
Multi(Primi)Parous - Foley and Oxytocin5.8
Secondary outcomeCount of participants· Assessed after delivery, on average occurring between 24-48 hours

Number of Vaginal Deliveries

GroupValue (Participants)
Nulliparous - Foley Only59
Nulliparous - Foley and Oxytocin49
Multi(Primi)Parous - Foley Only54
Multi(Primi)Parous - Foley and Oxytocin59
Secondary outcomeCount of participants· Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours

Regional Analgesia

GroupValue (Participants)
Nulliparous - Foley Only2
Nulliparous - Foley and Oxytocin13
Multi(Primi)Parous - Foley Only1
Multi(Primi)Parous - Foley and Oxytocin11
Secondary outcomeCount of participants· Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period

Obstetric Complications

GroupValue (Participants)
Nulliparous - Foley Only8
Nulliparous - Foley and Oxytocin10
Multi(Primi)Parous - Foley Only1
Multi(Primi)Parous - Foley and Oxytocin3
Secondary outcomeCount of participants· Assessed from birth through discharge, on average 2 days after birth

Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7

GroupValue (Participants)
Nulliparous - Foley Only27
Nulliparous - Foley and Oxytocin23
Multi(Primi)Parous - Foley Only12
Multi(Primi)Parous - Foley and Oxytocin11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Nulliparous - Foley OnlyNulliparous 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. Transcervical Foley catheter0 / 940 / 941 / 94
Nulliparous - Foley and OxytocinNulliparous 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. Oxytocin Transcervical Foley catheter0 / 900 / 900 / 90
Multi(Primi)Parous - Foley OnlyMultiparous 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. Transcervical Foley catheter0 / 670 / 670 / 67
Multi(Primi)Parous - Foley and OxytocinMultiparous 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. Oxytocin Transcervical Foley catheter0 / 710 / 711 / 71

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies10

Studies that cite this trial.

More studies

10 studies on this page

Indexing hint: Systematic review · 2023

Mechanical methods for induction of labour.

de Vaan et al. 2023The Cochrane database of systematic reviewscited by 38

PMID 36996264PMC10061553DOI 10.1002/14651858.cd001233.pub4PUB-36996264

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2021

Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score ≤3: a secondary analysis.

Gagnon et al. 2021American journal of obstetrics & gynecology MFMcited by 6

PMID 33757937DOI 10.1016/j.ajogmf.2021.100350PUB-33757937

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2017

Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial.

Schoen et al. 2017Obstetrics and gynecologycited by 33

PMID 28486381DOI 10.1097/aog.0000000000002032PUB-28486381

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2012

Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial.

Fitzpatrick et al. 2012The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricianscited by 8

PMID 21793769DOI 10.3109/14767058.2011.607522PUB-21793769

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2010

Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial.

Delaney et al. 2010Obstetrics and gynecologycited by 73

PMID 20502296DOI 10.1097/aog.0b013e3181dec6d0PUB-20502296

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2010

A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction.

Moraes Filho et al. 2010Acta obstetricia et gynecologica Scandinavicacited by 32

PMID 20636243DOI 10.3109/00016349.2010.499447PUB-20636243

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2009

Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening.

Kashanian et al. 2009International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetricscited by 29

PMID 19232606DOI 10.1016/j.ijgo.2009.01.005PUB-19232606

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2008

Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial.

Pettker et al. 2008Obstetrics and gynecologycited by 39

PMID 18515515DOI 10.1097/aog.0b013e31817615a0PUB-18515515

Full text at the publisher
Publisher page

PubMed tag: none · 2004

Cervical ripening with transcervical foley catheter and the risk of uterine rupture.

Bujold et al. 2004Obstetrics and gynecologycited by 75

PMID 14704239DOI 10.1097/01.aog.0000109148.23082.c1PUB-14704239

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2004

A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening.

Levy et al. 2004American journal of obstetrics and gynecologycited by 63

PMID 15547534DOI 10.1016/j.ajog.2004.03.033PUB-15547534

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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