A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Prelabor Rupture of Membranes and Unripe Cervices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwestern University
- Locations
- 1
- Primary Endpoint
- Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intracervical Balloon Catheter Group
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.
Intervention: Intracervical balloon catheter (Device)
Intracervical Balloon Catheter Group
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.
Intervention: Oxytocin (Drug)
Immediate low-dose oxytocin infusion group
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.
Intervention: Oxytocin (Drug)
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
Time Frame: 24-48 hours/duration of induction of labor
length of induction
Secondary Outcomes
- Cesarean delivery rate(24-48 hours/duration of induction of labor)
- Endometritis(from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections)
- Neonatal 5-minute Apgar score(5 minutes after delivery)
- chorioamnionitis(24-48 hours/duration of induction of labor)
- Neonatal umbilical arterial and venous acid base status(at the time of delivery)
- Length of first stage of labor(delivery (from initial cervical dilation to 10 cm cervical dilation]))
- Postpartum hemorrhage(at time of delivery and up to 24 hours after delivery)
- Epidural use(24-48 hours/duration of induction of labor)