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

Northwestern University

Status: Withdrawn

Conditions: Premature Rupture of Membrane; Unfavorable Cervix

Treatments: Drug: Oxytocin; Device: Intracervical balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03172858

STU00203535

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intracervical Balloon Catheter Group

Experimental group

Description:

The intracervical balloon catheter will be passed through the cervix either with a speculum exam or by a digital exam. Then the catheter balloon will be filled with 80 cc of sterile fluid. The catheter will be pulled to tension and taped to the patient's leg. Patients will have the option to IV pain medication at the time of intracervical balloon placement. The intracervical balloon will remain in place for 6 hours unless it falls out spontaneously. At the 6 hour mark, a vaginal exam will assess if the intracervical balloon has pulled through the cervix or if it needs further tension. The intracervical balloon will remain in place a maximum of 12 hours. After a maximum of 12 hours in place the intracervical balloon will be removed and oxytocin will be started per protocol.

Treatment:

Drug: Oxytocin

Device: Intracervical balloon catheter

Immediate low-dose oxytocin infusion group

Active Comparator group

Description:

At our institution the policy for oxytocin infusion is to start at a low dose of 2mu/min and to increase by 2mu/min at 15 to 20 minute intervals based on how often uterine contractions are occuring. A specific order from a physician is required to increase the oxytocin dose above 20 mu/min. Oxytocin will be titrated per usual protocol.

Treatment:

Drug: Oxytocin