Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00614432
First received: January 31, 2008
Last updated: December 16, 2010
Last verified: December 2010

January 31, 2008
December 16, 2010
January 2008
April 2010   (final data collection date for primary outcome measure)
Differences is intraoperative blood loss in anticoagulated versus non-anticoagulated women receiving a surgical termination of pregnancy. [ Time Frame: Post procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00614432 on ClinicalTrials.gov Archive Site
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Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. This study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.

We intend to conduct a prospective cohort study at Oregon Health and Science University and the University of Hawaii. This study will not be blinded and subjects will not be randomized. Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. For patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study.

We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment. This is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood

Non-Probability Sample

Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment.

Blood Loss
Not Provided
  • 1
    Women who are anticoagulated.
  • 2
    Matched case controls.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female seeking abortion services
  • Less than or equal to 12 weeks gestation
  • Age 18-50
  • Willing and able to sign informed consent
  • Use of Coumadin or LMW heparin (treatment group only)

Exclusion Criteria:

  • Unwilling or unable to sign informed consent
  • Women taking daily aspirin or herbal therapies containing gingko biloba
  • Women with a known history of a bleeding disorder such as von willebrand's disease
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614432
OHSU FAMPLAN 3861
No
Bliss Kaneshiro, MD, University of Hawaii
University of Hawaii
Oregon Health and Science University
Principal Investigator: Bliss Kaneshiro, M.D. University of Hawaii
Principal Investigator: Alison Edelman, M.D., M.P.H. Oregon Health and Science University
University of Hawaii
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP