Foley Bulb Insertion Method: Blind vs. Direct

Completed · Not applicable

Conditions studied: Pregnancy Related

In brief

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 primary outcome is rate of infection.

Key facts

Study ID

NCT03450408

Run by

The University of Texas Medical Branch, Galveston

People needed

372

Starts

2018-02-28

Expected to finish

2019-08-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women between the ages of 18 and 50 years
• Induction of labor
• Plan for Foley bulb placement by the managing obstetrics team

You may not qualify if…

• 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

Where it is running

• University of Texas Medical Branch John Sealy Hospital — Galveston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.