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NCT Number: NCT03079622

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

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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Key information

Conditions

Abortion in First Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electric Vacuum Aspiration

Procedure

Other names: Synevac® Vacuum Curettage System 10

Manual Vacuum Aspiration

Procedure

Other names: Ipas 60-mL double valve aspirator

Primary outcomes

  1. Operative time

    Time frame: Perioperative

    Time from cannula insertion until completion of uterine evacuation

Secondary outcomes

  1. Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure

    Time frame: Perioperative

  2. Provider acceptability

    Time frame: Perioperative

    • Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response)

  3. Patient acceptability

    Time frame: Perioperative and 2 weeks postoperatively

    • 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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2017
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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