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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women who are anticoagulated. | ||
| 2 | Matched case controls. |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume of Intraoperative Blood Loss | Quantitative blood loss using volume measurement and weight | Post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bliss Kaneshiro, M.D. | University of Hawaii | Principal Investigator |
| Alison Edelman, M.D., M.P.H. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii | Honolulu | Hawaii | 96822 | United States | ||
| Oregon Health and Science University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Women Who Are Anticoagulated | Women who are anticoagulated having surgical abortion below 12 weeks gestation |
| FG001 | Women Who Are Not Anticoagulated | Women who are not anticoagulated having surgical abortion less than 12 weeks gestation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Women Who Are Anticoagulated | Women who are anticoagulated. |
| BG001 | Matched Case Controls | Matched case controls. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of Intraoperative Blood Loss | Quantitative blood loss using volume measurement and weight | Posted | Mean | Standard Deviation | milliliters | Post procedure |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women Who Are Anticoagulated | Women who are anticoagulated. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| reaspiration | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Investigator | University of Hawaii | 808-203-6500 | whrc@hawaii.edu |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Whole blood
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Matched Case Controls | Matched case controls. | 0 | 6 | 0 | 6 | 0 | 6 |
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