Abortion, CompleteCERBINCT06456164
IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion
A study testing Cook Cervical Ripening Balloon in people with Abortion, Complete and Fetal Death, run by University of Chicago.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Complete, Fetal Death, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Cook Cervical Ripening Balloon
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 10 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maternal age ≥ 18
- English or Spanish-speaking
- Cervical dilation < 3 centimeters
- Gestational age between 22w0d and 27w6d
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Cook Cervical Ripening Balloon
- Keywords
- induction termination, medication abortion
- Medical subject headings
- Fetal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Cervical Ripening BalloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| Usual care with mechanical dilation | Experimental | 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. Receives: Device: Cook Cervical Ripening Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
Maternal temperature greater than 39°C or 38-38.9°C with evidence of leukocytosis or purulent cervical drainage
Measured: Up to 6 weeks post-delivery
Number of participants diagnosed with sepsis
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
Measured: Up to 6 weeks post-delivery
Number of participants diagnosed with septic shock
Hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation
Measured: Up to 6 weeks post-delivery
Number of participants diagnosed with postpartum hemorrhage
Estimated or quantitative blood loss greater than 1000 mL at the conclusion of expulsion of the fetus and placenta
Measured: Up to 6 weeks post-delivery
Number of participants requiring blood transfusion after expulsion of the fetus and placenta
Measured: Up to 6 weeks post-delivery
Number of participants requiring uterotonics
Need for misoprostol, carboprost, and/or methergine after expulsion of the fetus and/or placenta
Measured: Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration
Measured: During delivery hospitalization (within 72 hours after delivery)
Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
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
Measured: Up to 6 weeks post-delivery
Number of participants requiring hysterotomy or dilation and evacuation
Need for hysterotomy or dilation and evacuation in setting of failed induction of labor
Measured: During delivery hospitalization (within the first 72 hours after admission)
Number of participants diagnosed with a uterine rupture
Measured: Within the first 12 hours after expulsion of the fetus
Number of participants requiring intensive care unit admission
Measured: Up to 6 weeks post-delivery
Number of participants requiring readmission to the hospital within 6 weeks of delivery
Measured: Up to 6 weeks post-delivery
Number of participants who experience death
Measured: Up to 6 weeks post-delivery
Secondary outcomes (7)
Patient-reported pain
Use of visual analog scale (0-10), with higher scores indicating worse levels of pain
Measured: Up to 6 weeks post-delivery
Patient-reported distress
Impact of Event scale (0-88), with higher scores indicating higher levels of distress
Measured: Up to 6 weeks post-delivery
Patient-reported acceptability of intervention
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?"
Measured: Up to 6 weeks post-delivery
Patient-reported satisfaction
Client Satisfaction Questionnaire-8 (8-22), with higher scores indicating higher levels of satisfaction
Measured: During intrapartum period (up to 72 hours after delivery)
Total duration of labor, in hours
Total duration from initiation of misoprostol to expulsion of the fetus, in hours
Measured: During intrapartum period (up to 72 hours after delivery)
Total blood loss, in milliliters
Total blood loss after expulsion of the fetus and placenta
Measured: 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
Measured: Within the first 12 hours after expulsion of the fetus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Feb 2025 (estimated)
- Primary completion10 Apr 2025
- Study completion10 Apr 2025 (estimated)
Why it stopped: Study has not received IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, CompleteStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cook Cervical Ripening Balloon
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashish Premkumar, MD PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456164
- Sponsor's protocol ID
- IRB24-0835
- Acronym
- CERBI
- Status last verified
- Jun 2025
- First submitted
- 19 May 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once data are peer-reviewed and published, the investigators will plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06456164
- Acronym / sponsor ID
- CERBI / IRB24-0835
- Keywords
- induction termination, medication abortion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has not received IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cook Cervical Ripening Balloon
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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. |
| Usual care with mechanical dilation | Experimental | Device: Cook Cervical Ripening BalloonParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Maternal age ≥ 18
- English or Spanish-speaking
- Cervical dilation < 3 centimeters
- Gestational age between 22w0d and 27w6d
Key exclusion criteria (13 listed)
- Maternal age < 18
- Non-English- or Spanish-speaking
- Cervical dilation ≥ 3 centimeters
- Gestational age below 22w0d or above 27w6d
- Allergy to mifepristone or misoprostol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook Cervical Ripening BalloonThe 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. | Device | Usual care with mechanical dilation |
Primary outcome
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
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
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
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
Number of participants requiring blood transfusion after expulsion of the fetus and placenta
Time frame: 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
Number of participants diagnosed with a cervical laceration
Time frame: 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
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
Number of participants diagnosed with a uterine rupture
Time frame: 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
Number of participants requiring readmission to the hospital within 6 weeks of delivery
Time frame: Up to 6 weeks post-delivery
Number of participants who experience death
Time frame: Up to 6 weeks post-delivery
7 secondary outcomes
Patient-reported pain
Time frame: Up to 6 weeks post-delivery
Patient-reported distress
Time frame: Up to 6 weeks post-delivery
Patient-reported acceptability of intervention
Time frame: Up to 6 weeks post-delivery
Patient-reported satisfaction
Time frame: 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 blood loss, in milliliters
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: Yes. Once data are peer-reviewed and published, the investigators will plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish Premkumar, MD PhD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Cook Cervical Ripening Balloon in people with Abortion, Complete and Fetal Death, run by University of Chicago.
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 4 inclusion and 13 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis (time frame: Up to 6 weeks post-delivery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.