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Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 81 mg daily aspirin dose | No Intervention | obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA | |
| 162mg daily aspirin dose | Active Comparator | obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 162mg aspirin dose | Drug | 2 pills of 81mg aspirin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Diagnosis of Preeclampsia | by acog definitions | Through study completion, an average for 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2 | incomplete platelet inhibition measured by urinary TBx2 | Through study completion, an average for 10 months |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Medical Center Labor and Delivery Unit | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 81 mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA |
| FG001 | 162mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA 162mg aspirin dose: 2 pills of 81mg aspirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis population data was not obtained as we did not complete this study. No baseline data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 81 mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA |
| BG001 | 162mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA 162mg aspirin dose: 2 pills of 81mg aspirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Incidence of Diagnosis of Preeclampsia | by acog definitions | Study outcomes were not collected as no participants completed either 81 mg or 162 mg aspirin dose. Participation was terminated before completion of the study. | Posted | Through study completion, an average for 10 months |
|
Through study completion, an average for 10 months
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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 | 81 mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Rood, MD | The Ohio State University | 614-293-8515 | Kara.Rood@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2021 | Mar 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2 | incomplete platelet inhibition measured by urinary TBx2 | Study outcomes were not collected as no participants completed either 81 mg or 162 mg aspirin dose. Participation was terminated before completion of the study. | Posted | Through study completion, an average for 10 months |
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | 162mg Daily Aspirin Dose | obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA 162mg aspirin dose: 2 pills of 81mg aspirin | 0 | 76 | 0 | 76 | 0 | 76 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |