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

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• Status: Withdrawn
• Conditions: Fetal Death; Induction of Labor Affected Fetus / Newborn; Abortion, Complete
• Intervention / Treatment: Device: Cook Cervical Ripening Balloon

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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	Up to 6 weeks post-delivery
Number of participants requiring blood transfusion after expulsion of the fetus and placenta		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	Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration		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	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	During delivery hospitalization (within the first 72 hours after admission)
Number of participants diagnosed with a uterine rupture		Within the first 12 hours after expulsion of the fetus
Number of participants requiring intensive care unit admission		Up to 6 weeks post-delivery
Number of participants requiring readmission to the hospital within 6 weeks of delivery		Up to 6 weeks post-delivery
Number of participants who experience death		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	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	Up to 6 weeks post-delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported pain	Use of visual analog scale (0-10), with higher scores indicating worse levels of pain	Up to 6 weeks post-delivery
Patient-reported distress	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	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	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	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	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		Within the first 12 hours after expulsion of the fetus

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Ashish Premkumar, MD PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Actual): April 10, 2025
• Study Completion (Estimated): April 10, 2025

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: medication abortion; induction termination
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Fetal Death
• Other Study ID 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