Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices
- Conditions
- Premature Rupture of MembraneUnfavorable Cervix
- Interventions
- Device: Intracervical balloon catheter
- Registration Number
- NCT03172858
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracervical Balloon Catheter Group Intracervical balloon catheter 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. Intracervical Balloon Catheter Group Oxytocin 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. Immediate low-dose oxytocin infusion group Oxytocin 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.
- Primary Outcome Measures
Name Time Method Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours 24-48 hours/duration of induction of labor length of induction
- Secondary Outcome Measures
Name Time Method chorioamnionitis 24-48 hours/duration of induction of labor Maternal temperature \>100.4 F during labor with associated maternal or fetal tachycardia
Neonatal umbilical arterial and venous acid base status at the time of delivery assessment of acid-base status of neonate at the time of delivery
Cesarean delivery rate 24-48 hours/duration of induction of labor number of cesarean deliveries
Endometritis from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections temperature \>100.4 F in the postpartum period with initiation of antibiotics in postpartum period
Neonatal 5-minute Apgar score 5 minutes after delivery apgar score at 5 minutes of life after delivery of neonate
Length of first stage of labor delivery (from initial cervical dilation to 10 cm cervical dilation]) length of first stage of labor
Postpartum hemorrhage at time of delivery and up to 24 hours after delivery Estimated blood loss (EBL) \>500 cc from a vaginal delivery and EBL \>1000 cc from a cesarean delivery
Epidural use 24-48 hours/duration of induction of labor epidural anesthesia use during labor
Trial Locations
- Locations (1)
Prentice Women's Hospital
🇺🇸Chicago, Illinois, United States