Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks

Study Overview
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Brief Summary
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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).

Official Title
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Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks: A Randomized Trial

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Procedure: Electric Vacuum Aspiration
* Procedure: Manual Vacuum Aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 10 0/7 and 13 6/7 weeks of gestation Documented intra-uterine pregnancy Presenting for surgical induced abortion at RHS English-speaking Age 18 or older Exclusion Criteria: Spontaneous abortion Failed medical abortion Multiple gestation Uterine anomalies Lower uterine segment or cervical myomas History of 3 or more prior cesarean deliveries BMI > 40 Having the abortion procedure performed by a provider who does not perform MVA and EVA between 10 0/7 and 13 6/7 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electric vacuum aspiration<br>Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula. | Procedure: Electric Vacuum Aspiration<br> <br> * Other names: Synevac® Vacuum Curettage System 10;|
| Active Comparator: Manual vacuum aspiration<br>Manual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula. | Procedure: Manual Vacuum Aspiration<br> <br> * Other names: Ipas 60-mL double valve aspirator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Time from cannula insertion until completion of uterine evacuation | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |