Foley Bulb Insertion Method: Blind vs. Direct (FrIENDly)

Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: Method of placement of Foley bulb transcervical dilator

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, the obstetric team will notify the research team so that the patient may be screened for the study. If the patient consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the in-formed consent. After informed consent is obtained, the patient will be randomized to the study group (digital placement) or the control group (placement with a sterile speculum).

The control group will undergo induction of labor by placement via sterile speculum of a 22-French transcervical Foley catheter. The cervix is visualized with a sterile vaginal speculum and cleaned with iodine or chlorhexidine. A Foley catheter is introduced into the cervix and the bal-loon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.

The study group will undergo induction of labor by digital blind placement of a 22-French trans-cervical Foley catheter. A Foley catheter is introduced into the cervix using digits and hands wearing sterile gloves and the balloon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.

If cervix remains unfavorable after extraction of the dilators (< 3cm and at most 60% effaced), a second Foley catheter will be used in this case for a maximum of 12 hrs. No crossover will be allowed. In other words, a second Foley bulb will be placed in the same manner as the first assignment arm.

In any attempts, if the Foley bulb is not able to be placed in either insertion technique , a prostaglandin agent for cervical ripening may be used and insertion of the mechanical dilator can be re-attempted at a later time, as is the standard of care at our institution. No cross over will be allowed.

This will be an unblinded randomized clinical trial.

No significant adverse effects are expected with the use of transcervical Foley catheters for mechanical dilation. The most significant risks are vaginal bleeding due to cervical trauma and incidental rupture of membranes, as well as pain or discomfort with placement. The patient will undergo inpatient induction of labor, so any adverse reaction would be promptly detected and addressed.

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch John Sealy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placement with gloved hand; The Foley bulb transcervical dilator will be placed blindly with a gloved hand.	Procedure: Method of placement of Foley bulb transcervical dilator; This trial will assess two methods used to place a Foley bulb transcervical dilator.
Active Comparator: Placement with sterile speculum; 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; This trial will assess two methods used to place a Foley bulb transcervical dilator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Pooled maternal infection	Labor to 30 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal fever	Greater than or equal to 38 degrees Celsius	From beginning of labor process to time of discharge, up to seven days
Request for pain relief	Request for IV pain medications or epidural placement	Within 30 minutes of placement procedure
Vaginal bleeding	In the time period immediately following placement	Within 30 minutes of placement procedure
Artificial rupture of membranes	Rupture of amniotic sac	At time of placement of Foley bulb transcervical dilator
Chorioamnionitis or "triple I"	Presumptive or confirmed diagnosis	From beginning of labor process until time of delivery
Endometritis	Postpartum intrauterine infection	From time of delivery to 30 days postpartum

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Study Chair: Antonio F Saad, MD, University of Texas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-0359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No