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

NCT ID: NCT06456164

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-04-10

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Cook Cervical Ripening Balloon

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashish Premkumar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Other Identifiers

IRB24-0835

Identifier Type: -

Identifier Source: org_study_id