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

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

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).

Study Overview

• Status: Completed
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Procedure: Electric Vacuum Aspiration; Procedure: Manual Vacuum Aspiration

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Electric vacuum aspiration; Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula.	Procedure: Electric Vacuum Aspiration; Other Names: Synevac® Vacuum Curettage System 10
Active Comparator: 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.	Procedure: Manual Vacuum Aspiration; Other Names: Ipas 60-mL double valve aspirator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jaclyn M Grentzer, MD, MSCI, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share data, except de-identified data within our division.