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

Completed

• Conditions: Blood Loss

• Registration Number: NCT00614432
• Lead Sponsor: University of Hawaii

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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2018-05-22
• Results First Submitted QC: 2018-05-22
• Results First Posted: 2018-12-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of Intraoperative Blood Loss	Post procedure	Quantitative blood loss using volume measurement and weight

Trial Locations

Locations (2)

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States