Clinical trial NCT01085825: Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion
Official title: The Sensitivity of Manual Versus Electric Vacuum Aspiration to Detect Completed Abortion at Less Than Six Weeks of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Keywords: induced abortion
termination of pregnancy
manual vacuum aspiration
electric vacuum aspiration
Lead sponsor: Planned Parenthood of Greater New York
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2010-03-12
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Accurate Confirmation of Completed Abortion
timeFrame: 2 weeks - 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood of New York City - Margaret Sanger Center
state: New York
Study officials:
affiliation: Planned Parenthood of Greater New York
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.