Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy (APROACH-PK)

Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes

This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.

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) OR ≥2 risk factor: Nulliparity IVF pregnancy Black race or socioeconomic disadvantaged BMI>30 Prior adverse pregnancy outcome 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

Final results of this study will plan to be submitted for publication within 12 months of completion of analysis of samples. Following publication, a data set excluding any protected health information will be available on request pending agreement on use of data and appropriate IRB approval for data sharing agreement with the outside individuals or institutions requesting data. The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.

The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.