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

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ClinicalTrials.gov Identifier: NCT00614432
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Bliss Kaneshiro, University of Hawaii

Study Description
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Brief Summary:
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.

Condition or disease
Blood Loss

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort
1
Women who are anticoagulated.
2
Matched case controls.


Outcome Measures
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Primary Outcome Measures :
  1. Differences is Intraoperative Blood Loss in Anticoagulated Versus Non-anticoagulated Women Receiving a Surgical Termination of Pregnancy. [ Time Frame: Post procedure ]

Biospecimen Retention:   Samples Without DNA
Whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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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): NCT00614432


Locations
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United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96822
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
University of Hawaii
Oregon Health and Science University
Investigators
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Principal Investigator: Bliss Kaneshiro, M.D. University of Hawaii
Principal Investigator: Alison Edelman, M.D., M.P.H. Oregon Health and Science University
More Information
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Responsible Party: Bliss Kaneshiro, Associate Professor, University of Hawaii
ClinicalTrials.gov Identifier: NCT00614432    
Other Study ID Numbers: OHSU FAMPLAN 3861
First Posted: February 13, 2008    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018
Last Verified: May 2018
Keywords provided by Bliss Kaneshiro, University of Hawaii:
anticoagulation
surgical abortion
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes