Foley Bulb Insertion Method: Blind vs. Direct

Pregnancy Related Clinical Trial

— FrIENDly  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450408
• Other study ID #: 17-0359
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: August 1, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Procedure:
• Method of placement of Foley bulb transcervical dilator
This trial will assess two methods used to place a Foley bulb transcervical dilator.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch John Sealy Hospital	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

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