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

Phase 4

Terminated

• Conditions: Preeclampsia
• Interventions: Drug: 162mg aspirin dose

• Registration Number: NCT03735433
• Lead Sponsor: Ohio State University

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 Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40.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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Study Start: 2019-01-15
• Primary Completion: 2023-01-30
• Study Completion: 2024-03-01
• Results First Submitted: 2024-03-06
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Results First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

• BMI at enrollment >/= 30
• plan for ASA for preeclampsia prevention

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Exclusion Criteria

• BMI < 30
• already on ASA

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
162mg daily aspirin dose	162mg aspirin dose	obese women \>30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA

Primary Outcome Measures

Name	Time	Method
Incidence of Diagnosis of Preeclampsia	Through study completion, an average for 10 months	by acog definitions

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Ohio State Medical Center Labor and Delivery Unit; 🇺🇸 Columbus, Ohio, United States