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

Study Overview
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Brief Summary
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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
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There are not enough studies to support the use of intracervical balloon catheter (IBC) use in term premature 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.

Official Title
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A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Premature Rupture of Membranes and Unripe Cervices

Conditions
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Premature Rupture of Membrane, Unfavorable Cervix

Intervention / Treatment
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* Device: Intracervical balloon catheter
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracervical Balloon Catheter Group<br>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. | Device: Intracervical balloon catheter<br>* cervical ripening balloon<br>Drug: Oxytocin<br>* medication used to induce contractions<br>|
| Active Comparator: Immediate low-dose oxytocin infusion group<br>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. | Drug: Oxytocin<br>* medication used to induce contractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24-48 hours/duration of induction of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of first stage of labor | length of first stage of labor | delivery (from initial cervical dilation to 10 cm cervical dilation]) | 
| Cesarean delivery rate | number of cesarean deliveries | 24-48 hours/duration of induction of labor | 
| chorioamnionitis | Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia | 24-48 hours/duration of induction of labor | 
| Endometritis | temperature >100.4 F in the postpartum period with initiation of antibiotics in postpartum period | 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 | at time of delivery and up to 24 hours after delivery | 
| Epidural use | epidural anesthesia use during labor | 24-48 hours/duration of induction of labor | 
| Neonatal 5-minute Apgar score | apgar score at 5 minutes of life after delivery of neonate | 5 minutes after delivery | 
| Neonatal umbilical arterial and venous acid base status | assessment of acid-base status of neonate at the time of delivery | at the time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, term premature rupture of membrane, intracervical balloon catheter