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

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079622
• Other study ID #: 1.0
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: March 7, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Procedure:
• Electric Vacuum Aspiration

• Manual Vacuum Aspiration

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Time from cannula insertion until completion of uterine evacuation	Perioperative
Secondary	Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure		Perioperative
Secondary	Provider acceptability	1) Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response)	Perioperative
Secondary	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