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

The Washington University

Status: Completed

Conditions: Abortion in First Trimester

Treatments: Procedure: Manual Vacuum Aspiration; Procedure: Electric Vacuum Aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT03079622

1.0

Details and patient eligibility

About

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).

Enrollment: 146 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Electric vacuum aspiration

Active Comparator group

Description:

Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula.

Treatment:

Procedure: Electric Vacuum Aspiration

Manual vacuum aspiration

Active Comparator group

Description:

Manual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula.

Treatment:

Procedure: Manual Vacuum Aspiration