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Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients

NCT05514847 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-15

No results posted yet for this study

Summary

This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.

Conditions

Interventions

DRUG

Aspirin 81Mg Ec Tab

81 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

DRUG

Aspirin 162Mg Ec Tab

162 mg enteric coated aspirin, taken daily from before 14 weeks of gestational age through pregnancy

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Priyanka Kumar · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514847 on ClinicalTrials.gov