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Balloon Catheter for Cervical Ripening

NCT02606643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2018-11-07

Study results available
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Summary

Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure.

Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.

Conditions

  • Cervical Dilation

Interventions

PROCEDURE

Slight traction

Slight traction will be applied to the balloon catheter

PROCEDURE

Foley Catheter to no traction

Foley Catheter to no traction

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Gary Fruhman, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-07-31
Completion
2016-11-30

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 NCT02606643 on ClinicalTrials.gov