NCT01085825

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

June 8, 2015

Completed
Last Updated

February 1, 2017

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

March 10, 2010

Results QC Date

April 15, 2015

Last Update Submit

December 6, 2016

Conditions

Induced Abortion

Keywords

induced abortiontermination of pregnancymanual vacuum aspirationelectric vacuum aspiration

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Manual Vacuum Aspiration

ACTIVE COMPARATOR
Procedure: D & C abortion

Electric Vacuum Aspiration

ACTIVE COMPARATOR
Procedure: D & C abortion

Interventions

D & C abortionPROCEDURE

Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.

Electric Vacuum AspirationManual Vacuum Aspiration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood of New York City - Margaret Sanger Center

New York, New York, 10012, United States

Location

Related Publications (1)

  • 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.

    PMID: 25932839DERIVED

MeSH Terms

Interventions

Fumigant 93

Results Point of Contact

Title
Research Director
Organization
Planned Parenthood of NYC
cti@ppnyc.org
212-274-7255

Study Officials

  • Principal Investigator, MD, MPH

    Planned Parenthood of Greater New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 12, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Last Updated

February 1, 2017

Results First Posted

June 8, 2015

Record last verified: 2016-12

Locations

US(1)