NCT05514847

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

Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 ASA use. Currently, all patients that present to UVA Obstetric clinics are evaluated for development of preeclampsia per the current ACOG guidelines. If they screen positive per ACOG guidelines, then it is recommended they initiate 81mg/day ASA starting at 12 weeks of pregnancy and continuing until delivery. For this study, patients that present for early first trimester ultrasound (US) (for dating and/or genetic testing + ultrasound) will be offered enrollment in the study, and consenting patients will undergo double screening tests with ACOG and the FMF-based preeclampsia screen. This test will include first trimester uterine artery PI, assessment of maternal blood pressure, a maternal history and maternal serum markers including PAPP-A, PLGF, S-FLT, AFP. The first trimester preeclampsia screen will be performed between 10 weeks, 0 days and 13 weeks, 6 days of pregnancy. For the patients within the intervention group, repeat uterine artery PI measurements will be performed during the patient's 20-week anatomic survey ultrasound. Repeat maternal serum biomarkers will be collected with routine 28-week labs and at time of delivery (standard times for blood draws in pregnancy) for all enrolled patients. Patients will be followed longitudinally through their pregnancy and delivery and neonatal outcomes will be recorded. Delivery and timing of delivery will be based solely on obstetric indications regardless of status in the trial. All uterine artery Doppler measurements will be obtained by P.J. Kumar.

Conditions

• Preeclampsia
• Pregnancy Related

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2022-08-24
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study