Tension Versus no Tension With Foley Bulb Induction

NCT ID: NCT03588585

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Induction of Labor Affected Fetus / Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tension

foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.

Group Type ACTIVE_COMPARATOR

Tension

Intervention Type PROCEDURE

Tension applied to catheter and taped firmly to leg.

No tension

The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.

Group Type ACTIVE_COMPARATOR

NO TENSION

Intervention Type PROCEDURE

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

Interventions

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Tension

Tension applied to catheter and taped firmly to leg.

Intervention Type PROCEDURE

NO TENSION

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

Intervention Type PROCEDURE

Other Intervention Names

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misoprostil 25 mcg misoprostil 25 mcg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hawaii Pacific Health

OTHER

Sponsor Role lead

Responsible Party

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Holly Olson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Holly Olson, MD

Role: CONTACT

808-983-6000

Caroline Lau, MD

Role: CONTACT

808-983-6000

Facility Contacts

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Caroline Lau, MD

Role: primary

References

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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Other Identifiers

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2017-077

Identifier Type: -

Identifier Source: org_study_id

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