Blood Loss
Conditions
Keywords
anticoagulation, surgical abortion
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.
Interventions
None listed
Sponsors
Oregon Health and Science University
University of Hawaii
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Intraoperative Blood Loss | Post procedure | Quantitative blood loss using volume measurement and weight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women Who Are Anticoagulated Women who are anticoagulated. | 4 |
| Matched Case Controls Matched case controls. | 6 |
| Total | 10 |
Baseline characteristics
| Characteristic | Matched Case Controls | Women Who Are Anticoagulated | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 23.2 years STANDARD_DEVIATION 3 | 28.0 years STANDARD_DEVIATION 7.9 | 25.1 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 6 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 |
| other Total, other adverse events | 1 / 4 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 |
Outcome results
Primary
Volume of Intraoperative Blood Loss
Quantitative blood loss using volume measurement and weight
Time frame: Post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Who Are Anticoagulated | Volume of Intraoperative Blood Loss | 91.5 milliliters | Standard Deviation 88 |
| Matched Case Controls | Volume of Intraoperative Blood Loss | 52.2 milliliters | Standard Deviation 48 |