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NCT03450408: FrIENDly

Foley Bulb Insertion Method: Blind vs. Direct

Completed NA Last updated 7 May 2020
What this trial tests

NA trial testing Method of placement of Foley bulb transcervical dilator in Pregnancy Related in 372 participants. Completed in 1 August 2019.

Timeline
28 February 2018
Primary endpoint
28 February 2019
1 August 2019

Quick facts

Lead sponsorThe University of Texas Medical Branch, Galveston
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment372
Start date28 February 2018
Primary completion28 February 2019
Estimated completion1 August 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 18 to 50, female only, with Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.
    Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, et al · · 2021 · cited 9× · PMID 33278290 · DOI 10.1097/aog.0000000000004182

Verify or expand the search:

Other recruiting trials for Pregnancy Related

Currently open trials in the same condition.

Other The University of Texas Medical Branch, Galveston trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing