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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085825
First Posted: March 12, 2010
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.
  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 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.

Condition Intervention
Induced Abortion Procedure: D & C abortion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Accurate Confirmation of Completed Abortion [ Time Frame: 2 weeks - 6 months ]
    Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses


Enrollment: 500
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085825


Locations
United States, New York
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: Principal Investigator, MD, MPH Planned Parenthood of New York City, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier: NCT01085825     History of Changes
Other Study ID Numbers: PPNYC 001
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: April 15, 2015
Results First Posted: June 8, 2015
Last Update Posted: February 1, 2017
Last Verified: December 2016

Keywords provided by Planned Parenthood of New York City, Inc.:
induced abortion
termination of pregnancy
manual vacuum aspiration
electric vacuum aspiration