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

Study Overview
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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.

Official Title
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The Sensitivity of Manual Versus Electric Vacuum Aspiration to Detect Completed Abortion at Less Than Six Weeks of Pregnancy

Conditions
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Induced Abortion

Intervention / Treatment
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* Procedure: D & C abortion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Vacuum Aspiration<br> | Procedure: D & C abortion<br>* Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.<br>|
| Active Comparator: Electric Vacuum Aspiration<br> | Procedure: D & C abortion<br>* Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate Confirmation of Completed Abortion | Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses | 2 weeks - 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induced abortion, termination of pregnancy, manual vacuum aspiration, electric vacuum aspiration