Abortion in First TrimesterNCT03079622
Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks
A study testing Electric Vacuum Aspiration and Manual Vacuum Aspiration in people with Abortion in First Trimester, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Electric Vacuum Aspiration and Manual Vacuum Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: 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).
- Conditions
- Abortion in First Trimester
- Being tested
- Electric Vacuum Aspiration, Manual Vacuum Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric Vacuum AspirationProcedure or surgery
Also called Synevac® Vacuum Curettage System 10
Manual Vacuum AspirationProcedure or surgery
Also called Ipas 60-mL double valve aspirator
| Study group | Role | What they receive |
|---|---|---|
| Electric vacuum aspiration | Active comparator | Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula. Receives: Procedure: Electric Vacuum Aspiration |
| Manual vacuum aspiration | Active comparator | Manual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula. Receives: Procedure: Manual Vacuum Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time from cannula insertion until completion of uterine evacuation
Measured: Perioperative
Secondary outcomes (3)
Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure
Measured: Perioperative
Provider acceptability
- Ease of procedure on a 5 point Likert scale, 2) Appropriateness of method used for procedure (binary response)
Measured: Perioperative
Patient acceptability
- 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)
Measured: Perioperative and 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaclyn M Grentzer, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079622
- Sponsor's protocol ID
- 1.0
- Status last verified
- Mar 2017
- First submitted
- 18 Nov 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data, except de-identified data within our division.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03079622
- Acronym / sponsor ID
- 1.0
- Conditions
- Abortion in First Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric vacuum aspiration | Active comparator | Procedure: Electric Vacuum AspirationElectric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula. |
| Manual vacuum aspiration | Active comparator | Procedure: Manual Vacuum AspirationManual vacuum aspiration will be performed using the 60-mL double valve aspirator, manufactured by Ipas (Chapel Hill, NC, USA) with a flexible cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Spontaneous abortion
- Failed medical abortion
- Multiple gestation
- Uterine anomalies
- Lower uterine segment or cervical myomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric Vacuum AspirationAlso: Synevac® Vacuum Curettage System 10 | Procedure or surgery | Electric vacuum aspiration |
| Manual Vacuum AspirationAlso: Ipas 60-mL double valve aspirator | Procedure or surgery | Manual vacuum aspiration |
Primary outcome
Operative time
Time frame: Perioperative
Time from cannula insertion until completion of uterine evacuation
3 secondary outcomes
Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure
Time frame: Perioperative
Provider acceptability
Time frame: Perioperative
Patient acceptability
Time frame: Perioperative and 2 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: No. There is no plan to share data, except de-identified data within our division.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn M Grentzer, MD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Vacuum Aspiration and Manual Vacuum Aspiration in people with Abortion in First Trimester, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.