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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273115
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : June 5, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Corina Schoen, Christiana Care Health Services

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.

Condition or disease Intervention/treatment Phase
Labor; Forced or Induced, Affecting Fetus or Newborn Drug: Oxytocin Device: Transcervical Foley catheter Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
Study Start Date : October 2014
Actual Primary Completion Date : September 11, 2016
Actual Study Completion Date : September 11, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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 Name: 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 Name: 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 Name: 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 Name: Transcervical Foley balloon




Primary Outcome Measures :
  1. Delivery Rate [ Time Frame: Within 24 hours ]
    The rate of women who deliver in less than or equal to 24 hours from Foley placement.


Secondary Outcome Measures :
  1. 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

  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 ]
    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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273115


Locations
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United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Christiana Care Health Services
Thomas Jefferson University
Investigators
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Principal Investigator: Corina Schoen, MD Sidney Kimmel Medical College at Thomas Jefferson University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Corina Schoen, Maternal Fetal Medicine Fellow, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT02273115    
Other Study ID Numbers: CCC-34107
First Posted: October 23, 2014    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Corina Schoen, Christiana Care Health Services:
induction
Foley catheter
oxytocin
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs