Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion
Recruitment status was Not yet recruiting
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Purpose
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 492 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.
| Condition | Intervention |
|---|---|
|
Induced Abortion |
Procedure: D & C abortion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Sensitivity of Manual Versus Electric Vacuum Aspiration to Detect Completed Abortion at Less Than Six Weeks of Pregnancy |
- To compare the sensitivity for detection of completed abortion at less than six weeks of pregnancy using manual vacuum aspiration (MVA) and electric vacuum aspiration (EVA). [ Time Frame: 14 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 492 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Manual Vacuum Aspiration |
Procedure: D & C abortion
Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
|
| Active Comparator: Electric Vacuum Aspiration |
Procedure: D & C abortion
Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Lauren Porsch, MPH | 212-274-7255 | lauren.porsch@ppnyc.org |
| United States, New York | |
| Planned Parenthood of New York City - Boro Hall Center | Not yet recruiting |
| Brooklyn, New York, United States, 11201 | |
| Contact: Lauren Porsch, MPH lauren.porsch@ppnyc.org | |
| Principal Investigator: Gillian Dean, MD, MPH | |
| Planned Parenthood of New York City - Margaret Sanger Center | Not yet recruiting |
| New York, New York, United States, 10012 | |
| Contact: Lauren Porsch, MPH lauren.porsch@ppnyc.org | |
| Principal Investigator: | Gillian Dean, MD, MPH | Planned Parenthood of New York City, Inc. |
More Information
No publications provided
| Responsible Party: | Gillian Dean, MD, MPH, Planned Parenthood of New York City, Inc. |
| ClinicalTrials.gov Identifier: | NCT01085825 History of Changes |
| Other Study ID Numbers: | PPNYC 001 |
| Study First Received: | March 10, 2010 |
| Last Updated: | March 19, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Planned Parenthood of New York City, Inc.:
|
induced abortion termination of pregnancy manual vacuum aspiration electric vacuum aspiration |
ClinicalTrials.gov processed this record on June 17, 2013