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Tension Versus no Tension With Foley Bulb Induction

Not Applicable
Recruiting
Conditions
Induction of Labor Affected Fetus / Newborn
Registration Number
NCT03588585
Lead Sponsor
Hawaii Pacific Health
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Time to DeliveryWill measure length of time from beginning of induction with the foley balloon until delivery

Reduction in time to delivery

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kapiolani Medical Center for Women and Children

🇺🇸

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Caroline Lau, MD
Contact

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