Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX)

June 2, 2017 updated by: Corina Schoen, Christiana Care Health Services

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Transcervical Foley catheter
Other Names:
  • Transcervical Foley balloon
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.
Drug: Oxytocin
Device: Transcervical Foley catheter
Other Names:
  • Transcervical Foley balloon
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.
Device: Transcervical Foley catheter
Other Names:
  • Transcervical Foley balloon
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.
Drug: Oxytocin
Device: Transcervical Foley catheter
Other Names:
  • Transcervical Foley balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery Rate
Time Frame: Within 24 hours
The rate of women who deliver in less than or equal to 24 hours from Foley placement.
Within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 12 hours
Total Time to Delivery
Time Frame: On average, 24-36 hours
On average, 24-36 hours
Time to Foley Expulsion
Time Frame: 0-12 hours
0-12 hours
Number of Vaginal Deliveries
Time Frame: Assessed after delivery, on average occurring between 24-48 hours
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
Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
Obstetric Complications
Time Frame: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
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
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
Assessed from birth through discharge, on average 2 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

Thomas Jefferson University

Investigators

  • Principal Investigator: Corina Schoen, MD, Sidney Kimmel Medical College at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 11, 2016

Study Completion (Actual)

September 11, 2016

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC-34107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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