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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placement with gloved hand | Active Comparator | The Foley bulb transcervical dilator will be placed blindly with a gloved hand. |
|
| Placement with sterile speculum | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Method of placement of Foley bulb transcervical dilator | Procedure | This trial will assess two methods used to place a Foley bulb transcervical dilator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Pooled maternal infection | Labor to 30 days postpartum |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
As we are assessing pregnant patients, participants will be female.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio F Saad, MD | University of Texas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch John Sealy Hospital | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278290 | Derived | 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. |
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The individual or individuals responsible for assessing outcome data will be blinded to group assignment.
| 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 |