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

Not Applicable

Completed

• Conditions: Abortion in First Trimester
• Interventions: Procedure: Electric Vacuum Aspiration; Procedure: Manual Vacuum Aspiration

• Registration Number: NCT03079622
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-07
• Last Update Submitted: 2017-03-07
• Study First Posted: 2017-03-14
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric vacuum aspiration	Electric Vacuum Aspiration	Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula.
Manual vacuum aspiration	Manual Vacuum Aspiration	Manual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula.

Primary Outcome Measures

Name	Time	Method
Operative time	Perioperative	Time from cannula insertion until completion of uterine evacuation

Secondary Outcome Measures

Name	Time	Method
Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure	Perioperative
Provider acceptability	Perioperative	1) Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response)
Patient acceptability	Perioperative and 2 weeks postoperatively	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)

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States