Clinical trial NCT03172858: Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices
Official title: A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Prelabor Rupture of Membranes and Unripe Cervices
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Premature Rupture of Membrane
Unfavorable Cervix
Keywords: cervical ripening
term premature rupture of membrane
intracervical balloon catheter
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours
timeFrame: 24-48 hours/duration of induction of labor
Secondary outcomes:
measure: Length of first stage of labor
timeFrame: delivery (from initial cervical dilation to 10 cm cervical dilation])
measure: Cesarean delivery rate
timeFrame: 24-48 hours/duration of induction of labor
measure: chorioamnionitis
timeFrame: 24-48 hours/duration of induction of labor
measure: Endometritis
timeFrame: from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections
measure: Postpartum hemorrhage
timeFrame: at time of delivery and up to 24 hours after delivery
measure: Epidural use
timeFrame: 24-48 hours/duration of induction of labor
measure: Neonatal 5-minute Apgar score
timeFrame: 5 minutes after delivery
measure: Neonatal umbilical arterial and venous acid base status
timeFrame: at the time of delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Whitney You, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
citation: Bond DM, Middleton P, Levett KM, van der Ham DP, Crowther CA, Buchanan SL, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome. Cochrane Database Syst Rev. 2017 Mar 3;3(3):CD004735. doi: 10.1002/14651858.CD004735.pub4.
citation: Mackeen AD, Walker L, Ruhstaller K, Schuster M, Sciscione A. Foley catheter vs prostaglandin as ripening agent in pregnant women with premature rupture of membranes. J Am Osteopath Assoc. 2014 Sep;114(9):686-92. doi: 10.7556/jaoa.2014.137.
citation: Cabrera IB, Quinones JN, Durie D, Rust J, Smulian JC, Scorza WE. Use of intracervical balloons and chorioamnionitis in term premature rupture of membranes. J Matern Fetal Neonatal Med. 2016 Mar;29(6):967-71. doi: 10.3109/14767058.2015.1027191. Epub 2015 Sep 25.