Clinical trial NCT00614432: Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Official title: Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss
Keywords: anticoagulation
surgical abortion
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2008-02-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Volume of Intraoperative Blood Loss
timeFrame: Post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: University of Hawaii
name: Bliss Kaneshiro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Alison Edelman, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: