Study Results
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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RECRUITING
NA
150 participants
INTERVENTIONAL
2018-04-16
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Tension
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.
NO TENSION
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.
NO TENSION
Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cephalic presentation
* Intact fetal membranes
* Bishop score less than or equal to 6
* Age greater than or equal to 18 years
Exclusion Criteria
* Multiple gestation
* Previous uterine/cervical surgery
* Ruptured fetal membranes
* Fetal malpresentation
* Any contraindication to vaginal delivery at time of admission
18 Years
FEMALE
No
Sponsors
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Hawaii Pacific Health
OTHER
Responsible Party
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Holly Olson
Assistant Professor
Locations
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Countries
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Central Contacts
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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.
Other Identifiers
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2017-077
Identifier Type: -
Identifier Source: org_study_id
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