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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier:
NCT01085825
First received: March 10, 2010
Last updated: October 27, 2014
Last verified: October 2014
  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

Further study details as provided by Planned Parenthood of New York City, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 498
Study Start Date: April 2010
Primary Completion Date: October 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085825

Locations
United States, New York
Planned Parenthood of New York City - Boro Hall Center
Brooklyn, New York, United States, 11201
Planned Parenthood of New York City - Margaret Sanger Center
New York, New York, United States, 10012
Sponsors and Collaborators
Planned Parenthood of New York City, Inc.
Society of Family Planning
Investigators
Principal Investigator: Gillian Dean, MD, MPH Planned Parenthood of New York City, Inc.
  More Information

No publications provided

Responsible Party: 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: October 27, 2014
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 November 19, 2014