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

Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03172858
• Other study ID #: STU00203535
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 2020

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Rupture of Membrane
• Rupture
• Unfavorable Cervix

Intervention

Device:
• Intracervical balloon catheter
cervical ripening balloon

Drug:
• Oxytocin
medication used to induce contractions

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of first stage of labor	length of first stage of labor	delivery (from initial cervical dilation to 10 cm cervical dilation])
Secondary	Cesarean delivery rate	number of cesarean deliveries	24-48 hours/duration of induction of labor
Secondary	chorioamnionitis	Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia	24-48 hours/duration of induction of labor
Secondary	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
Secondary	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
Secondary	Epidural use	epidural anesthesia use during labor	24-48 hours/duration of induction of labor
Secondary	Neonatal 5-minute Apgar score	apgar score at 5 minutes of life after delivery of neonate	5 minutes after delivery
Secondary	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