ClinicalTrials.gov processed this data on March 19, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00614432OHSU FAMPLAN 3861NCT00614432Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated WomenBlood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated WomenUniversity of HawaiiOtherOregon Health and Science UniversityOtherNo
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.
CompletedJanuary 2008April 2010April 2010ObservationalNoCohortProspectiveVolume of Intraoperative Blood LossPost procedureQuantitative blood loss using volume measurement and weight210Blood Loss1Women who are anticoagulated.2Matched case controls.Samples Without DNA
Whole blood
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.
Non-Probability Sample
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
Female18 Years50 YearsAccepts Healthy VolunteersBliss Kaneshiro, M.D.Principal InvestigatorUniversity of HawaiiAlison Edelman, M.D., M.P.H.Principal InvestigatorOregon Health and Science UniversityUniversity of HawaiiHonoluluHawaii96822United StatesOregon Health and Science UniversityPortlandOregon97239United StatesUnited StatesJuly 2022January 31, 2008February 12, 2008February 13, 2008May 22, 2018May 22, 2018December 14, 2018July 1, 2022July 1, 2022July 18, 2022Principal InvestigatorUniversity of HawaiiBliss KaneshiroAssociate Professoranticoagulationsurgical abortionHemorrhage