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

NCT ID: NCT03079622

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Abortion in First Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electric vacuum aspiration

Electric vacuum aspiration will be performed with Synevac® Vacuum Curettage System 10 (Richmond, CA, USA) with a rigid cannula.

Group Type ACTIVE_COMPARATOR

Electric Vacuum Aspiration

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Manual Vacuum Aspiration

Intervention Type PROCEDURE

Interventions

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Electric Vacuum Aspiration

Intervention Type PROCEDURE

Manual Vacuum Aspiration

Intervention Type PROCEDURE

Other Intervention Names

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Synevac® Vacuum Curettage System 10 Ipas 60-mL double valve aspirator

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaclyn M Grentzer, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1.0

Identifier Type: -

Identifier Source: org_study_id

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