IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI)

June 3, 2025 updated by: University of Chicago

IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial

The goal of this research is to understand whether it is practical and safe to use an intracervical balloon catheter in addition to standard of care medications at the time of an induction of labor for an abortion or fetal death. The medical device used in this study is cleared by the Food and Drug Administration (FDA) and is used for induction of labor at term gestational ages (at or above 37 weeks of gestation). The study team will also collect data about patient-level experiences with the procedure, time in labor, and labor-related complications, such as higher-than-expected blood loss or infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Commonly, induction of labor in the second trimester is accomplished with the use of oral anti-progestin medications (i.e., mifepristone) at least 24 hours prior to administration of sublingual, buccal, or vaginal prostaglandins (e.g., misoprostol). Innovation over the past decade has largely been focused on the concomitant use of mechanical dilation for induction of labor in order to reduce the time from initiation of labor to delivery. However, limited data exist to demonstrate the efficacy of an intracervical balloon catheter during second-trimester induction of labor. Therefore, the principal investigator seeks to conduct a feasibility randomized controlled trial to evaluate whether an intracervical balloon catheter - commonly used for inductions of labor at later gestational ages - can be used during second-trimester inductions of labor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Maternal age ≥ 18
  • English or Spanish-speaking
  • Cervical dilation < 3 centimeters
  • Gestational age between 22w0d and 27w6d

Exclusion Criteria:

  • Maternal age < 18
  • Non-English- or Spanish-speaking
  • Cervical dilation ≥ 3 centimeters
  • Gestational age below 22w0d or above 27w6d
  • Allergy to mifepristone or misoprostol
  • Hemolysis, Elevated Liver Enzymes, and Low Platelets (HELLP) syndrome
  • Disseminated intravascular coagulopathy
  • Placenta previa or suspected placenta accreta spectrum disorder
  • Placental abruption
  • Suspected intraamniotic infection
  • Rupture of membranes
  • Untreated genitourinary tract infection
  • 3 or more cesarean deliveries, classical cesarean delivery, or endometrial cavity-entering myomectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Participants will receive mifepristone 200 mg by mouth 24 hours prior to induction of labor. Labor will be induced with use of vaginal misoprostol according to regimens endorsed by the American College of Obstetricians and Gynecologists and the Society of Family Planning.
Experimental: Usual care with mechanical dilation
Participants will receive mifepristone 200 mg by mouth 24 hours prior to induction of labor. Participants will have their labor induced concomitantly with misoprostol (according to the regimen described in the "Usual Care" arm) and placement of the Cook Cervical Ripening Balloon.
Device: Cook Cervical Ripening Balloon
The Cook Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction when the cervix is unfavorable for induction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
Time Frame: Up to 6 weeks post-delivery
Maternal temperature greater than 39°C or 38-38.9°C with evidence of leukocytosis or purulent cervical drainage
Up to 6 weeks post-delivery
Number of participants diagnosed with postpartum hemorrhage
Time Frame: Up to 6 weeks post-delivery
Estimated or quantitative blood loss greater than 1000 mL at the conclusion of expulsion of the fetus and placenta
Up to 6 weeks post-delivery
Number of participants requiring blood transfusion after expulsion of the fetus and placenta
Time Frame: Up to 6 weeks post-delivery
Up to 6 weeks post-delivery
Number of participants requiring uterotonics
Time Frame: Up to 6 weeks post-delivery
Need for misoprostol, carboprost, and/or methergine after expulsion of the fetus and/or placenta
Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration
Time Frame: During delivery hospitalization (within 72 hours after delivery)
During delivery hospitalization (within 72 hours after delivery)
Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
Time Frame: Up to 6 weeks post-delivery
Dilation and curettage, insertion of intrauterine tamponade device (i.e., Bakri or Jada devices), uterine artery embolization, exploratory laparotomy, O'Leary and/or B-Lynch sutures, and/or other uterine-conserving surgical measures to control hemorrhage
Up to 6 weeks post-delivery
Number of participants requiring hysterotomy or dilation and evacuation
Time Frame: During delivery hospitalization (within the first 72 hours after admission)
Need for hysterotomy or dilation and evacuation in setting of failed induction of labor
During delivery hospitalization (within the first 72 hours after admission)
Number of participants diagnosed with a uterine rupture
Time Frame: Within the first 12 hours after expulsion of the fetus
Within the first 12 hours after expulsion of the fetus
Number of participants requiring intensive care unit admission
Time Frame: Up to 6 weeks post-delivery
Up to 6 weeks post-delivery
Number of participants requiring readmission to the hospital within 6 weeks of delivery
Time Frame: Up to 6 weeks post-delivery
Up to 6 weeks post-delivery
Number of participants who experience death
Time Frame: Up to 6 weeks post-delivery
Up to 6 weeks post-delivery
Number of participants diagnosed with sepsis
Time Frame: Up to 6 weeks post-delivery
Sepsis in Obstetrics Score > 6. Score calculated from maximum maternal temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, white blood cell count, and serum lactic acid
Up to 6 weeks post-delivery
Number of participants diagnosed with septic shock
Time Frame: Up to 6 weeks post-delivery
Hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation
Up to 6 weeks post-delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-reported pain
Time Frame: Up to 6 weeks post-delivery
Use of visual analog scale (0-10), with higher scores indicating worse levels of pain
Up to 6 weeks post-delivery
Patient-reported distress
Time Frame: Up to 6 weeks post-delivery
Impact of Event scale (0-88), with higher scores indicating higher levels of distress
Up to 6 weeks post-delivery
Patient-reported acceptability of intervention
Time Frame: Up to 6 weeks post-delivery
assessed via the question "Would you have the same procedure again if you had to have another second-trimester induction of labor?" and "Did you think the second-trimester induction of labor was better or worse than expected?"
Up to 6 weeks post-delivery
Patient-reported satisfaction
Time Frame: During intrapartum period (up to 72 hours after delivery)
Client Satisfaction Questionnaire-8 (8-22), with higher scores indicating higher levels of satisfaction
During intrapartum period (up to 72 hours after delivery)
Total duration of labor, in hours
Time Frame: During intrapartum period (up to 72 hours after delivery)
Total duration from initiation of misoprostol to expulsion of the fetus, in hours
During intrapartum period (up to 72 hours after delivery)
Total blood loss, in milliliters
Time Frame: Within the first 24 hours after expulsion of the fetus and placenta
Total blood loss after expulsion of the fetus and placenta
Within the first 24 hours after expulsion of the fetus and placenta
Number of participants requiring dilation and curettage or manual extraction of the placenta
Time Frame: Within the first 12 hours after expulsion of the fetus
Within the first 12 hours after expulsion of the fetus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashish Premkumar, MD PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB24-0835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once data are peer-reviewed and published, the investigators will plan to share individual participant data with other researchers.

IPD Sharing Time Frame

Within 1 year after completion of data analysis,

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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