Foley Bulb Insertion Method: Blind vs. Direct

NCT03450408 | Completed DMC

• 1 other identifier: 17-0359
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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 primary outcome is rate of infection.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Infection

  Pooled maternal infection

  Labor to 30 days postpartum

Secondary Outcomes (6)

• Maternal fever

  From beginning of labor process to time of discharge, up to seven days

• Request for pain relief

  Within 30 minutes of placement procedure

• Vaginal bleeding

  Within 30 minutes of placement procedure

• Artificial rupture of membranes

  At time of placement of Foley bulb transcervical dilator

• Chorioamnionitis or "triple I"

  From beginning of labor process until time of delivery

Study Arms (2)

Placement with gloved hand

ACTIVE COMPARATOR

The Foley bulb transcervical dilator will be placed blindly with a gloved hand.

Procedure: Method of placement of Foley bulb transcervical dilator

Placement with sterile speculum

ACTIVE COMPARATOR

The cervix will be directly visualized using a sterile speculum, and an instrument will be used to advance the Foley bulb transcervical dilator into the cervical os.

Procedure: Method of placement of Foley bulb transcervical dilator

Interventions

Method of placement of Foley bulb transcervical dilator PROCEDURE

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

Placement with gloved hand; Placement with sterile speculum

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: As we are assessing pregnant patients, participants will be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch John Sealy Hospital

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.

  PMID: 33278290 DERIVED

Study Officials

• Antonio F Saad, MD

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual or individuals responsible for assessing outcome data will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 1, 2018
• Study Start: February 28, 2018
• Primary Completion: February 28, 2019
• Study Completion: August 1, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)