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The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan-S | Placebo Comparator | A number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own. |
|
| Foley balloon | Experimental | A Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Foley Balloon | Device | Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Time to speculum in to speculum out | Up to approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Dilation | Measure the cervical dilation after removal of the Foley balloon or Dilapan-S | Beginning of the procedure (approximately 5 seconds to assess) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39067560 | Derived | Liu SM, Henkel A, Meza P, Shorter JM, Cahill E, Blumenthal PD, Shaw KA. Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial. Contraception. 2024 Dec;140:110550. doi: 10.1016/j.contraception.2024.110550. Epub 2024 Jul 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dilapan-S | Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age. |
| FG001 | Foley Balloon | Foley balloon inserted for cervical preparation and filled to 30mL of water or saline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dilapan-S | Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age. |
| BG001 | Foley Balloon | Foley balloon inserted for cervical preparation and filled to 30mL of water or saline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedure Time | Time to speculum in to speculum out | Posted | Mean | Standard Deviation | minutes | Up to approximately 30 minutes |
|
|
Up to 48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dilapan-S | Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage from atony | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Team | Stanford University | (650) 497-5175 | gynresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Mar 12, 2024 | Prot_SAP_000.pdf |
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| Dilapan-S | Device | Dilapan S will be placed through the cervix on the day prior to the procedure |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants could select more than one option to indicate they identify with more than one race, ethnicity, or nationality. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Cervical Dilation | Measure the cervical dilation after removal of the Foley balloon or Dilapan-S | Posted | Count of Participants | Participants | Beginning of the procedure (approximately 5 seconds to assess) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Foley Balloon | Foley balloon inserted for cervical preparation and filled to 30mL of water or saline. | 0 | 16 | 0 | 16 | 2 | 16 |
| Cervical abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cervical laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| 2 cm |
|
| 3 cm |
|
| ≥ 4 cm |
|