TerminatedPhase 4

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

Stopped: futility

United States152 participantsStarted 2019-01-15

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI at enrollment \>/= 30 * plan for ASA for preeclampsia prevention Exclusion Criteria: * BMI \< 30 * already on ASA

What they're measuring

Incidence of Diagnosis of Preeclampsia

Timeframe: Through study completion, an average for 10 months

Trial details

NCT IDNCT03735433

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-30

Results submitted2024-03-06

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