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This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation & Evacuation (D&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.
The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D&E operative time.
Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcervical single-balloon catheter group | Experimental | Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter. |
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| Osmotic dilators group | Active Comparator | Participants randomized to this arm will have cervical dilation done using osmotic dilators. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcervical single-balloon catheter | Device | A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own. |
| Measure | Description | Time Frame |
|---|---|---|
| Dilation & Evacuation (D&E) Operative time | the total duration in D&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case. | at end of procedure about 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Participant preoperative pain | Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D&E. Higher scores are associated with more pain. | every hour until procedure, on average 3 hours |
| Participant satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anjanique Mariquit Lu, MD | Contact | 617 414 5716 | anjaniquemariquit.lu@bmc.org | |
| Alana Martinusen, MPH | Contact | 617 383 3500 | alana.martinusen@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Anjanique Mariquit Lu, MD | Boston Medical Center, Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D&E.
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| Synthetic osmotic dilators | Device | Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter. |
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Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied. |
| after dilation, on average 3 hours |
| Cervical dilation | Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon. | beginning of procedure, on average 3 hours |
| Number of participants with adequate cervical dilation | Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed. | beginning of procedure, on average 3 hours |
| Number of participants with surgery completed in the same day | Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no. | 12 months |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |