Clinical Trials Directory

Trials / Completed

CompletedNCT01085825

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
500 (actual)
Sponsor
Planned Parenthood of Greater New York · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURED & C abortionParticipants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Timeline

Start date
2010-04-01
Primary completion
2011-10-01
First posted
2010-03-12
Last updated
2017-02-01
Results posted
2015-06-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01085825. Inclusion in this directory is not an endorsement.