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Foley Bulb Insertion Method: Blind vs. Direct

NCT03450408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2020-05-07

No results posted yet for this study

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 primary outcome is rate of infection.

Conditions

  • Pregnancy Related

Interventions

PROCEDURE

Method of placement of Foley bulb transcervical dilator

This trial will assess two methods used to place a Foley bulb transcervical dilator.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Antonio F Saad, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-02-28
Completion
2019-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450408 on ClinicalTrials.gov