Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies. However, approximately one third of abortion facilities do not offer abortions at less than six weeks of pregnancy. Providers may be concerned that they will be unable to identify products of conception (POCs) in uterine aspirates after early abortion and about the time, cost and risk associated with following serum hCG levels when completed abortion cannot be confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA) causes less destruction of pregnancy tissue and therefore may increase the likelihood of identifying POCs on gross inspection. No published reports specifically compare MVA to electric vacuum aspiration (EVA) for the detection of complete products of conception and none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation at a large inner city family planning center. We will measure positive identification of POCs on gross inspection in patients subsequently shown to have completed abortions. We hypothesize that the rate of true positive detection of POCs will be higher in dilation and curettage (D\&C) using MVA than EVA.

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Detailed Description

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Conditions

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Induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Manual Vacuum Aspiration

Group Type ACTIVE_COMPARATOR

D & C abortion

Intervention Type PROCEDURE

Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Electric Vacuum Aspiration

Group Type ACTIVE_COMPARATOR

D & C abortion

Intervention Type PROCEDURE

Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Interventions

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D & C abortion

Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* gestational sac size \<12 mm or no visible sac (with positive pregnancy test) day of surgical abortion
* no medical contraindications to outpatient abortion at study site

Exclusion Criteria

* not able to consent
* suspected ectopic pregnancy (pelvic mass, unilateral pain, or detection on ultrasound), suspected molar pregnancy, or no sac and vaginal bleeding suspicious for completed spontaneous abortion
* failed medication abortion

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes