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

NCT03172858 | Withdrawn FDA Device

• 1 other identifier: STU00203535
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Rupture of Membrane; Unfavorable Cervix

Keywords

cervical ripening; term premature rupture of membrane; intracervical balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Length of first stage of labor

  delivery (from initial cervical dilation to 10 cm cervical dilation])

• Cesarean delivery rate

  24-48 hours/duration of induction of labor

• chorioamnionitis

  24-48 hours/duration of induction of labor

• Endometritis

  from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections

• Postpartum hemorrhage

  at time of delivery and up to 24 hours after delivery

Study Arms (2)

Intracervical Balloon Catheter Group

EXPERIMENTAL

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; Drug: Oxytocin

Immediate low-dose oxytocin infusion group

ACTIVE COMPARATOR

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

Interventions

Intracervical balloon catheter DEVICE

cervical ripening balloon

Intracervical Balloon Catheter Group

Oxytocin DRUG

medication used to induce contractions

Immediate low-dose oxytocin infusion group; Intracervical Balloon Catheter Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 8598837 BACKGROUND

• 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.

  PMID: 28257562 BACKGROUND

• 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.

  PMID: 25170038 BACKGROUND

• 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.

  PMID: 25845274 BACKGROUND

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Whitney You, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: June 1, 2017
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

US (1)