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The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum aspiration (EVA). The investigators hypothesize that operative times will be increased when using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric vacuum aspiration | Active Comparator | Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula. |
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| Manual vacuum aspiration | Active Comparator | Manual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric Vacuum Aspiration | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time from cannula insertion until completion of uterine evacuation | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure | Perioperative | |
| Provider acceptability | 1) Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclyn M Grentzer, MD, MSCI | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
There is no plan to share data, except de-identified data within our division.
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| Manual Vacuum Aspiration |
| Procedure |
|
|
| Perioperative |
| Patient acceptability | 1) Satisfaction with procedure on 4-point rating scale 2) Would choose same procedure again (binary response) 3) Would recommend procedure to a friend (binary response) | Perioperative and 2 weeks postoperatively |