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Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours

NCT03086967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2022-11-30

Study results available
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Summary

The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.

Conditions

  • Induction of Labor Affected Fetus / Newborn

Interventions

DEVICE

Double-lumen balloon catheter

introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Susan A Bliss, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-09-30
Completion
2016-02-29

Countries

  • United States

Study Locations

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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 NCT03086967 on ClinicalTrials.gov