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Premature Rupture of MembraneNCT03172858

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

A study testing Intracervical balloon catheter and Oxytocin in people with Premature Rupture of Membrane and Unfavorable Cervix, run by Northwestern University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Intracervical balloon catheter and Oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Nov 2018to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Prentice Women's Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Intracervical balloon catheter, Oxytocin
Keywords
cervical ripening, term premature rupture of membrane, intracervical balloon catheter
Medical subject headings
Fetal Membranes, Premature Rupture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracervical balloon catheterDevice

    cervical ripening balloon

  • OxytocinDrug

    medication used to induce contractions

Study groups in NCT03172858
Study groupRoleWhat they receive
Intracervical Balloon Catheter GroupExperimentalThe 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.
Receives: Device: Intracervical balloon catheter; Drug: Oxytocin
Immediate low-dose oxytocin infusion groupActive comparatorAt 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.
Receives: Drug: Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24-48 hours/duration of induction of labor

Secondary outcomes (8)

  1. Length of first stage of labor

    length of first stage of labor

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

  2. Cesarean delivery rate

    number of cesarean deliveries

    Measured: 24-48 hours/duration of induction of labor

  3. chorioamnionitis

    Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia

    Measured: 24-48 hours/duration of induction of labor

  4. Endometritis

    temperature >100.4 F in the postpartum period with initiation of antibiotics in postpartum period

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

  5. Postpartum hemorrhage

    Estimated blood loss (EBL) >500 cc from a vaginal delivery and EBL >1000 cc from a cesarean delivery

    Measured: at time of delivery and up to 24 hours after delivery

  6. Epidural use

    epidural anesthesia use during labor

    Measured: 24-48 hours/duration of induction of labor

  7. Neonatal 5-minute Apgar score

    apgar score at 5 minutes of life after delivery of neonate

    Measured: 5 minutes after delivery

  8. Neonatal umbilical arterial and venous acid base status

    assessment of acid-base status of neonate at the time of delivery

    Measured: at the time of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2017
  2. Study start1 Nov 2018
  3. Primary completionMay 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Why it stopped: The IRB identified too many safety issues and the study did not move ahead.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03172858
Sponsor's protocol ID
STU00203535
Status last verified
Mar 2024
First submitted
19 Apr 2017
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 8598837

  • 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.

    PubMed 28257562

  • 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.

    PubMed 25170038

  • 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.

    PubMed 25845274

  • 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.

    PubMed 36996264

Questions about this trial

What is this clinical trial studying?

A study testing Intracervical balloon catheter and Oxytocin in people with Premature Rupture of Membrane and Unfavorable Cervix, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours (time frame: 24-48 hours/duration of induction of labor). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03172858, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.

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