Premature Rupture of Membrane, Unfavorable Cervix
Conditions
Keywords
cervical ripening, term premature rupture of membrane, intracervical balloon catheter
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.
Interventions
cervical ripening balloon
DRUGOxytocin
medication used to induce contractions
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cesarean delivery rate | 24-48 hours/duration of induction of labor | number of cesarean deliveries |
| chorioamnionitis | 24-48 hours/duration of induction of labor | Maternal temperature \>100.4 F during labor with associated maternal or fetal tachycardia |
| 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 |
| Length of first stage of labor | delivery (from initial cervical dilation to 10 cm cervical dilation]) | length of first stage of labor |
| Epidural use | 24-48 hours/duration of induction of labor | epidural anesthesia use during labor |
| Neonatal 5-minute Apgar score | 5 minutes after delivery | apgar score at 5 minutes of life after delivery of neonate |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed