Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

NCT ID: NCT02273115

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-11

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.

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.

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcervical Foley catheter

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Transcervical Foley catheter

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Transcervical Foley catheter

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Transcervical Foley catheter

Intervention Type: DEVICE

Interventions

Oxytocin

Intervention Type: DRUG

Transcervical Foley catheter

Intervention Type: DEVICE

Other Intervention Names

Transcervical Foley balloon

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Corina Schoen

Maternal Fetal Medicine Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corina Schoen, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Medical College at Thomas Jefferson University

Locations

Christiana Care Health Services

Newark, Delaware, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

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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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 28486381 (View on PubMed)

Other Identifiers

CCC-34107

Identifier Type: -

Identifier Source: org_study_id