drugset / Trial / NCT03735433

The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia

NCT03735433 ↗

Phase 4 Terminated 152 enrolled Ohio State University
RandomizedParallel-groupOpen-labelTreatment

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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.

Timeline

Start
2019-01-15
Primary completion
2023-01-30
Completion
2024-03-01

Outcome

Outcome not reported

Stopped: “futility”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 162 mg —

Indications