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Tension Versus no Tension With Foley Bulb Induction

Sponsor
Hawaii Pacific Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03588585
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
58.5
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tension
  • Procedure: NO TENSION
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
Actual Study Start Date :
Apr 16, 2018
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tension

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

Procedure: Tension
Tension applied to catheter and taped firmly to leg.
Other Names:
  • misoprostil 25 mcg

    		•
    Active Comparator: 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.

    Procedure: NO TENSION
    Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same
    Other Names:
  • misoprostil 25 mcg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Delivery [Will measure length of time from beginning of induction with the foley balloon until delivery]

      Reduction in time to delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826

    Sponsors and Collaborators

    • Hawaii Pacific Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Holly Olson, Assistant Professor, Hawaii Pacific Health
    ClinicalTrials.gov Identifier:
    NCT03588585
    Other Study ID Numbers:
    • 2017-077
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Aug 8, 2022