Tension Versus no Tension With Foley Bulb Induction
Not Applicable
Recruiting
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Procedure: TensionProcedure: NO TENSION
- 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
- Arm && Interventions
Group Intervention Description Tension Tension foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault. No tension 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.
- Primary Outcome Measures
Name Time Method Time to Delivery Will measure length of time from beginning of induction with the foley balloon until delivery Reduction in time to delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States