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

Induced Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085825
• Other study ID #: PPNYC 001
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: February 11, 2016
• Start date: April 2010

Study information

• Verified date: February 2016
• Source: Planned Parenthood of New York City, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Procedure:
• D & C abortion
Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Locations

Country	Name	City	State
United States	Planned Parenthood of New York City - Boro Hall Center	Brooklyn	New York
United States	Planned Parenthood of New York City - Margaret Sanger Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood of New York City, Inc.	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks - 6 months	No