Antenatal Platelet Response on Aspirin and Correlation With Hypertensive Disorders of Pregnancy: a Pharmacokinetic Study Through Pregnancy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); March of Dimes
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• <16 weeks' gestational age

• Singleton pregnancy

• Plan to take 81mg aspirin due to high risk history (below), but not yet initiated

• ≥1 risk factor:

• Chronic hypertension

• Type I or II diabetes

• Previous preeclampsia

• Renal disease

• Autoimmune disease (SLE)

Exclusion Criteria:

• Contraindication to aspirin

• Current or planned use of any other anticoagulation

• Current need for dialysis

• Use of aspirin therapy prior to enrollment in the current pregnancy

• Thrombocytopenia (<150)

• Other known platelet disorder/thrombophilia at enrollment