A Phase 4 interventional study of 162mg aspirin dose in Preeclampsia, sponsored by Ohio State University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Ohio State University · Phase 4, Interventional, and Treatment
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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 152 is above the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Exclusion Criteria:
obese women \>30 BMI at risk for preeclampsia will receive recommended 81mg ASA
obese women \>30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA
Drug: 162mg aspirin dose
2 pills of 81mg aspirin
Incidence of Diagnosis of Preeclampsia
by acog definitions
Time frame: Through study completion, an average for 10 months
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
| Milestone | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose |
|---|---|---|
| Started | 76 | 76 |
| Completed | 0 | 0 |
| Not completed | 76 | 76 |
by acog definitions
No measurements were reported for this outcome.
incomplete platelet inhibition measured by urinary TBx2
No measurements were reported for this outcome.
Collected over Through study completion, an average for 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 81 mg Daily Aspirin Dose | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| 162mg Daily Aspirin Dose | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
Baseline analysis population data was not obtained as we did not complete this study. No baseline data was collected.
| Age, Categorical | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose | Total |
|---|
| Sex: Female, Male | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose | Total |
|---|
| Region of Enrollment(participants) | 81 mg Daily Aspirin Dose | 162mg Daily Aspirin Dose | Total |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jan 2019 to primary completion in Jan 2023, 48 months.
Results were first posted in Apr 2024, 1 year 2 months after primary completion.
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This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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