Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tension Versus no Tension With Foley Bulb Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588585
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Holly Olson, Hawaii Pacific Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Induction of Labor Affected Fetus / Newborn Procedure: Tension Procedure: NO TENSION Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 16, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: misoprostil 25 mcg


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to Delivery [ Time Frame: Will measure length of time from beginning of induction with the foley balloon until delivery ]
    Reduction in time to delivery


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588585


Contacts
Layout table for location contacts
Contact: Holly Olson, MD 808-983-6000
Contact: Caroline Lau, MD 808-983-6000 cgy@hawaii.edu

Locations
Layout table for location information
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Caroline Lau, MD         
Sponsors and Collaborators
Hawaii Pacific Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Holly Olson, Assistant Professor, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT03588585    
Other Study ID Numbers: 2017-077
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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