Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks
1 other identifier
interventional
146
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedMarch 14, 2017
March 1, 2017
7 months
November 18, 2015
March 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Operative time
Time from cannula insertion until completion of uterine evacuation
Perioperative
Secondary Outcomes (3)
Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure
Perioperative
Provider acceptability
Perioperative
Patient acceptability
Perioperative and 2 weeks postoperatively
Study Arms (2)
Electric vacuum aspiration
ACTIVE COMPARATORElectric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula.
Manual vacuum aspiration
ACTIVE COMPARATORManual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jaclyn M Grentzer, MD, MSCI
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
March 14, 2017
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
March 14, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share data, except de-identified data within our division.