Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
The individual or individuals responsible for assessing outcome data will be blinded to group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Texas Medical Branch John Sealy Hospital
Galveston, Texas 77555
Contact:
Maggie J Kuhlmann-Capek, MD
409-789-7784
makuhlma@utmb.edu

More Details

NCT ID
NCT03450408
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Maggie J Kuhlmann-Capek, MD
4097897784
makuhlma@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.