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

NCT06456164 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ashish Premkumar, MD PhD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-04-10
Completion
2025-04-10
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456164 on ClinicalTrials.gov