Foley Bulb Insertion Method: Blind vs. Direct

NCT ID: NCT03450408

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-08-01

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placement with gloved hand

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

Group Type: ACTIVE_COMPARATOR

Method of placement of Foley bulb transcervical dilator

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Method of placement of Foley bulb transcervical dilator

Intervention Type: PROCEDURE

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

Interventions

Method of placement of Foley bulb transcervical dilator

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio F Saad, MD

Role: STUDY_CHAIR

University of Texas

Locations

University of Texas Medical Branch John Sealy Hospital

Galveston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33278290 (View on PubMed)

Other Identifiers

17-0359

Identifier Type: -

Identifier Source: org_study_id