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Completed

NCT Number: NCT00614432

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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Hawaii, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Volume of Intraoperative Blood Loss

    Time frame: Post procedure

    Quantitative blood loss using volume measurement and weight

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Oregon Health and Science University

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 13, 2008
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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