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

NCT06456164 | Withdrawn DMC FDA Device

• 1 other identifier: IRB24-0835
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Abortion, Complete; Fetal Death; Induction of Labor Affected Fetus / Newborn

Keywords

induction termination; medication abortion

Outcome Measures

Primary Outcomes (13)

• 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 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

• 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

Secondary Outcomes (7)

• Patient-reported pain

  Up to 6 weeks post-delivery

• Patient-reported distress

  Up to 6 weeks post-delivery

• Patient-reported acceptability of intervention

  Up to 6 weeks post-delivery

• Patient-reported satisfaction

  During intrapartum period (up to 72 hours after delivery)

• Total duration of labor, in hours

  During intrapartum period (up to 72 hours after delivery)

Study Arms (2)

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.

Device: Cook Cervical Ripening Balloon

Interventions

Cook Cervical Ripening Balloon DEVICE

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.

Usual care with mechanical dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• or more cesarean deliveries, classical cesarean delivery, or endometrial cavity-entering myomectomy

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Fetal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashish Premkumar, MD PhD

  University of Chicago

  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: Cook Cervical Ripening Balloon

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 13, 2024
• Study Start: February 1, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 1 year after completion of data analysis,