Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women - Full Text View

Sponsors and Collaborators:	University of Hawaii Oregon Health and Science University Society of Family Planning
Information provided by:	University of Hawaii
ClinicalTrials.gov Identifier:	NCT00614432

Purpose

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
Blood Loss

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women

Further study details as provided by University of Hawaii:

Primary Outcome Measures:

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

Biospecimen Description:

Whole blood

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614432

Contacts

Contact: Women's Health Research Unit Confidential Recruitment Line

(503) 494-3666

whru@ohsu.edu

Locations

United States, Hawaii
University of Hawaii	Not yet recruiting
Honolulu, Hawaii, United States, 96822
Principal Investigator: Bliss Kaneshiro, M.D.
United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Alison Edelman, M.D., M.P.H.
Sub-Investigator: Jeffrey Jensen, M.D., M.P.H.
Sub-Investigator: Paula Bednarek, M.D.
Sub-Investigator: Mark Nichols, M.D.
Sub-Investigator: Marcella Messerle Forbes, FNP
Sub-Investigator: Andrea O'Donnell, FNP

Sponsors and Collaborators

University of Hawaii

Oregon Health and Science University

Society of Family Planning

Investigators

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

(Women's Health Research Unit website) This link exits the ClinicalTrials.gov site

Responsible Party:	University of Hawaii ( Bliss Kaneshiro, MD )
Study ID Numbers:	OHSU FAMPLAN 3861
Study First Received:	January 31, 2008
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00614432
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Hawaii:

anticoagulation
surgical abortion

Study placed in the following topic categories:

Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009