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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women|
- 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 ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Women who are anticoagulated.
Matched case controls.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614432
|United States, Hawaii|
|University of Hawaii|
|Honolulu, Hawaii, United States, 96822|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Bliss Kaneshiro, M.D.||University of Hawaii|
|Principal Investigator:||Alison Edelman, M.D., M.P.H.||Oregon Health and Science University|