Status:
COMPLETED
Foley Bulb Insertion Method: Blind vs. Direct
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The...
Detailed Description
The target population for this study is women who present for scheduled induction of labor. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripen-ning,...
Eligibility Criteria
Inclusion
- Women between the ages of 18 and 50 years
- Induction of labor
- Plan for Foley bulb placement by the managing obstetrics team
Exclusion
- Patient unwilling or unable to provide consent
- Fetal demise or major congenital anomaly
- Immunosuppressed patients: i.e., taking systemic immunosuppressants or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4\<200, or other
- Fever (\>38°C) in the 48 hours prior to presentation for induction of labor
- Use of anti-pyretic agent (i.e., acetaminophen) in the eight hours preceding admission for induction of labor
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT03450408
Start Date
February 28 2018
End Date
August 1 2019
Last Update
May 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Medical Branch John Sealy Hospital
Galveston, Texas, United States, 77555