Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion
Primary Purpose
Induced Abortion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D & C abortion
Sponsored by
About this trial
This is an interventional diagnostic trial for Induced Abortion focused on measuring induced abortion, termination of pregnancy, manual vacuum aspiration, electric vacuum aspiration
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
Sites / Locations
- Planned Parenthood of New York City - Margaret Sanger Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Manual Vacuum Aspiration
Electric Vacuum Aspiration
Arm Description
Outcomes
Primary Outcome Measures
Accurate Confirmation of Completed Abortion
Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses
Secondary Outcome Measures
Full Information
NCT ID
NCT01085825
First Posted
March 10, 2010
Last Updated
December 6, 2016
Sponsor
Planned Parenthood of Greater New York
Collaborators
Society of Family Planning
1. Study Identification
Unique Protocol Identification Number
NCT01085825
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Planned Parenthood of Greater New York
Collaborators
Society of Family Planning
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induced Abortion
Keywords
induced abortion, termination of pregnancy, manual vacuum aspiration, electric vacuum aspiration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Vacuum Aspiration
Arm Type
Active Comparator
Arm Title
Electric Vacuum Aspiration
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
D & C abortion
Intervention Description
Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
Primary Outcome Measure Information:
Title
Accurate Confirmation of Completed Abortion
Description
Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses
Time Frame
2 weeks - 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Principal Investigator, MD, MPH
Organizational Affiliation
Planned Parenthood of Greater New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood of New York City - Margaret Sanger Center
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25932839
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.
Results Reference
derived
Learn more about this trial
Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion
We'll reach out to this number within 24 hrs