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Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

NCT05922111 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-06-28

No results posted yet for this study

Summary

The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.

Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.

Conditions

  • Induction of Labor

Interventions

DEVICE

cervical ripening balloon for one hour

The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room

DEVICE

cervical ripening balloon for twelve hours

The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Naphtali Justman · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-12-31
Completion
2026-06-30

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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 NCT05922111 on ClinicalTrials.gov