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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Vacuum Aspiration | Active Comparator |
| |
| Electric Vacuum Aspiration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D & C abortion | Procedure | Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | Planned Parenthood of Greater New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of New York City - Margaret Sanger Center | New York | New York | 10012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25932839 | Derived | Dean G, Colarossi L, Porsch L, Betancourt G, Jacobs A, Paul ME. Manual compared with electric vacuum aspiration for abortion at less than 6 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1121-1129. doi: 10.1097/AOG.0000000000000787. |
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We enrolled a total of 500 women from April 22, 2010 to October 14, 2011; 252 women were randomized to MVA and 248 to EVA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Vacuum Aspiration | D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. |
| FG001 | Electric Vacuum Aspiration | D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Vacuum Aspiration | D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. |
| BG001 | Electric Vacuum Aspiration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 2 weeks - 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Vacuum Aspiration | D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Director | Planned Parenthood of NYC | 212-274-7255 | cti@ppnyc.org |
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| ID | Term |
|---|---|
| C007792 | Fumigant 93 |
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D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Mean sac diameter | Mean | Standard Deviation | mm |
|
|
|
|
| 0 |
| 252 |
| 0 |
| 252 |
| EG001 | Electric Vacuum Aspiration | D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. | 0 | 248 | 0 | 248 |
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