Foley Bulb Insertion Method: Blind vs. Direct

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Procedure: Method of placement of Foley bulb transcervical dilator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placement with gloved hand<br>The Foley bulb transcervical dilator will be placed blindly with a gloved hand. | Procedure: Method of placement of Foley bulb transcervical dilator<br>* This trial will assess two methods used to place a Foley bulb transcervical dilator.<br>|
| Active Comparator: Placement with sterile speculum<br>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<br>* This trial will assess two methods used to place a Foley bulb transcervical dilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Pooled maternal infection | Labor to 30 days postpartum | 

Secondary Outcome Measures

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