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N/A N=500 Randomized Diagnostic

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

Induced Abortion

Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Accurate Confirmation of Completed Abortion — 182; 164 participants — p=.13

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
D & C abortion (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Planned Parenthood of Greater New York
Primary completion
Oct 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Accurate Confirmation of Completed Abortion
182; 164 .13

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01085825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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