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

• ClinicalTrials.gov Identifier: NCT03450408
• Recruitment Status: Completed
• First Posted: March 1, 2018
• Last Update Posted: May 7, 2020
• Sponsor: The University of Texas Medical Branch, Galveston
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Related	Procedure: Method of placement of Foley bulb transcervical dilator	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 372 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The individual or individuals responsible for assessing outcome data will be blinded to group assignment.
• Primary Purpose: Prevention
• Official Title: Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial
• Actual Study Start Date: February 28, 2018
• Actual Primary Completion Date: February 28, 2019
• Actual Study Completion Date: August 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Infection [ Time Frame: Labor to 30 days postpartum ]
   Pooled maternal infection

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: As we are assessing pregnant patients, participants will be female.
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Texas

University of Texas Medical Branch John Sealy Hospital

Galveston, Texas, United States, 77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

• Study Chair: Antonio F Saad, MD; University of Texas

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03450408
• Other Study ID Numbers: 17-0359
• First Posted: March 1, 2018
• Last Update Posted: May 7, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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