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Tension Versus no Tension With Foley Bulb Induction

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03588585
Enrollment
86
Registered
2018-07-17
Start date
2018-04-16
Completion date
2026-02-09
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

Brief summary

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

Detailed 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.

Interventions

PROCEDURETension

Tension applied to catheter and taped firmly to leg.

PROCEDURENO TENSION

Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same

Sponsors

Hawaii Pacific Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to DeliveryWill measure length of time from beginning of induction with the foley balloon until deliveryReduction in time to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026