Clinical trial NCT03450408: Foley Bulb Insertion Method: Blind vs. Direct
Official title: Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Infection
timeFrame: Labor to 30 days postpartum
Secondary outcomes:
measure: Maternal fever
timeFrame: From beginning of labor process to time of discharge, up to seven days
measure: Request for pain relief
timeFrame: Within 30 minutes of placement procedure
measure: Vaginal bleeding
timeFrame: Within 30 minutes of placement procedure
measure: Artificial rupture of membranes
timeFrame: At time of placement of Foley bulb transcervical dilator
measure: Chorioamnionitis or "triple I"
timeFrame: From beginning of labor process until time of delivery
measure: Endometritis
timeFrame: From time of delivery to 30 days postpartum
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch John Sealy Hospital
state: Texas
Study officials:
affiliation: University of Texas
name: Antonio F Saad, MD
role: STUDY_CHAIR
References:
citation: 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.