Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
1 other identifier
observational
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2008
Typical duration for all trials
2 active sites
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
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
December 14, 2018
CompletedJuly 18, 2022
July 1, 2022
2.2 years
January 31, 2008
May 22, 2018
July 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of Intraoperative Blood Loss
Quantitative blood loss using volume measurement and weight
Post procedure
Study Arms (2)
1
Women who are anticoagulated.
2
Matched case controls.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Hawaiilead
- Oregon Health and Science Universitycollaborator
Study Sites (2)
University of Hawaii
Honolulu, Hawaii, 96822, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Investigator
- Organization
- University of Hawaii
Study Officials
- PRINCIPAL INVESTIGATOR
Bliss Kaneshiro, M.D.
University of Hawaii
- PRINCIPAL INVESTIGATOR
Alison Edelman, M.D., M.P.H.
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
January 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 18, 2022
Results First Posted
December 14, 2018
Record last verified: 2022-07