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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Ages 18-50

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Pregnant female in the first trimester.

• Ability to take oral medication and be willing to adhere to the aspirin regimen

• Patient has a prenatal ultrasound between 11+0 through 13+6 days of gestation

• Patient who has low or high risks for preeclampsia by the ACOG (American College of Obstetricians and Gynecologists) screening tool, and low or high risks for the FMF prescreening tool for preeclampsia.

Exclusion Criteria:

• ASA allergy, known hypersensitivity to NSAIDS

• Patients with nasal polyps

• Patients with aspirin-induced asthma exacerbations

• Active peptic ulcer disease

• Severe hepatic dysfunction

• History of GI bleeding

• Pregnancy with major abnormalities demonstrated on the 11-13-week scan

• Patient presents beyond 13w6d for first prenatal visit

• Age < 18

• Non-viable pregnancy