Preeclampsia
Conditions
Keywords
aspirin, obesity
Brief summary
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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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.
Detailed description
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.
Interventions
DRUG162mg aspirin dose
2 pills of 81mg aspirin
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* BMI at enrollment \>/= 30 * plan for ASA for preeclampsia prevention
Exclusion criteria
* BMI \< 30 * already on ASA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Diagnosis of Preeclampsia | Through study completion, an average for 10 months | by acog definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2 | Through study completion, an average for 10 months | incomplete platelet inhibition measured by urinary TBx2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 81 mg Daily Aspirin Dose obese women \>30 BMI at risk for preeclampsia will receive recommended 81mg ASA | 0 |
| 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 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 76 |
| other Total, other adverse events | 0 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 |
Outcome results
Primary
Incidence of Diagnosis of Preeclampsia
by acog definitions
Time frame: Through study completion, an average for 10 months
Population: 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.
Secondary
Incidence of Aspirin Resistance Based on Incomplete Inhibition of TBx2
incomplete platelet inhibition measured by urinary TBx2
Time frame: Through study completion, an average for 10 months
Population: 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.