Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

Christiana Care Health Services323 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

323

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Interventions

OxytocinDRUG

Transcervical Foley catheterDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Christiana Care Health Services

Newark, Delaware, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Delivery Rate

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

Time frame: Within 24 hours

Secondary Outcomes

Number of Participants With Time to Delivery Achieved Within 12 Hours

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

Time frame: Within 12 hours

Total Time to Delivery

Time frame: On average, 24-36 hours

Time to Foley Expulsion

Time frame: 0-12 hours

Number of Vaginal Deliveries

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

Regional Analgesia

Regional analgesia used during Foley ripening

Time frame: 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

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

Neonatal Outcome: Neonatal Weight

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

Data from ClinicalTrials.gov

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