Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

Northwestern University

Overview

This study is designed to determine if an intracervical balloon catheter (IBC) is better than oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or breaking the bag of water prior to onset of labor. The investigators suspect that an intracervical balloon catheter will shorten the time interval from initiation of induction of labor to delivery.

There are not enough studies to support the use of intracervical balloon catheter (IBC) in term prelabor rupture of membranes (PROM). Prospective randomized studies comparing IBC placement to oxytocin use in induction of labor for term PROM do not exist. Intracervical Balloon Catheter has been shown to reduce duration of labor for women with intact membranes undergoing induction of labor. The practice at this institution is to use oxytocin to start contractions when a woman has PROM. This study will examine IBC compared to oxytocin use in term PROM. This will allow for the evaluation of a cervical ripening method for term PROM that may improve women's outcomes. Other outcomes for this study are rates of infection during labor, cesarean section, and adverse maternal and/or neonatal outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Premature Rupture of Membrane Unfavorable Cervix

Interventions

Intracervical balloon catheterDEVICE

cervical ripening balloon

OxytocinDRUG

medication used to induce contractions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Nulliparous women, Women aged 18-50 years, Singleton gestation, Vertex presentation, Live fetus, Rupture of membranes confirmed by sterile speculum examination \> 37 weeks of gestation at time of rupture of membranes, Bishop score \< 6 Exclusion Criteria: Multiparous women, Bishop score \>6, Multifetal gestation, Contraindication to labor including placenta previa , Maternal fever prior to randomization: T \>100.4 F , Known fetal anomalies

Locations (1)

Prentice Women's Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours

length of induction

Time frame: 24-48 hours/duration of induction of labor

Secondary Outcomes

Length of first stage of labor

length of first stage of labor

Time frame: delivery (from initial cervical dilation to 10 cm cervical dilation])

Cesarean delivery rate

number of cesarean deliveries

Time frame: 24-48 hours/duration of induction of labor

chorioamnionitis

Maternal temperature \>100.4 F during labor with associated maternal or fetal tachycardia

Time frame: 24-48 hours/duration of induction of labor

Endometritis

temperature \>100.4 F in the postpartum period with initiation of antibiotics in postpartum period

Time frame: from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections

Postpartum hemorrhage

Estimated blood loss (EBL) \>500 cc from a vaginal delivery and EBL \>1000 cc from a cesarean delivery

Time frame: at time of delivery and up to 24 hours after delivery

Epidural use

epidural anesthesia use during labor

Time frame: 24-48 hours/duration of induction of labor

Neonatal 5-minute Apgar score

Data from ClinicalTrials.gov

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