Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia.

Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John O'Brien, MD
• Treatments: Aspirin

Criteria

Inclusion Criteria (control)

• No risk factors for preeclampsia

Inclusion Criteria (pre-eclampsia)

• History of preterm preeclampsia

• Chronic hypertension

• Type 1 and Type 2 diabetes

• Renal diseases

• Autoimmune disease

Exclusion Criteria

• Pregnant women younger than 18 years or older than 45 years

• Multiple gestations

• History of allergy (urticaria or anaphylaxis) to aspirin or aspirin-related products asthma that worsens after aspirin use

• Patients with gastrointestinal or genitourinary bleeding

• Patients with peptic ulcer disease

• Patients with severe liver dysfunction

• Patients who have undergone bypass surgery

• Patients on anticoagulant medication(s)

• Women with anomalous fetus