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NCT03588585 Clinical Trial

Tension Versus no Tension With Foley Bulb Induction

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:
A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03588585
Other study ID # 2017-077
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date March 2025

Study information
Verified date February 2024
Source Hawaii Pacific Health
Contact Holly Olson, MD
Phone 808-983-6000
Email olsonh@hawaii.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Description:

Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children. - Cephalic presentation - Intact fetal membranes - Bishop score less than or equal to 6 - Age greater than or equal to 18 years Exclusion Criteria: - Multiparas - Multiple gestation - Previous uterine/cervical surgery - Ruptured fetal membranes - Fetal malpresentation - Any contraindication to vaginal delivery at time of admission

Study Design

Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Procedure:
• Tension
Tension applied to catheter and taped firmly to leg.
• NO TENSION
Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same

Locations
Country Name City State
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii

Sponsors (1)
Lead Sponsor Collaborator
Hawaii Pacific Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Delivery Reduction in time to delivery Will measure length of time from beginning of induction with the foley balloon until delivery
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