Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)

NCT04295850 | Completed FDA Drug

• 2 other identifiers: 19F.887R21HD101127
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (4)

• Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP)

  Difference in first trimester PFA-100 closure time between patients started on aspirin who do and do not develop HDP

  8 months (delivery)

• Aim 2: Pharmacogenomics of aspirin

  Difference in PFA-100 closure time with aspirin therapy based on platelet receptor genotype

  2 weeks

• Aim 3: MicroRNAs and HDP

  Regression analysis to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels in first trimester are associated with risk of HDP

  8 months (delivery)

• Aim 4: Aspirin pharmacokinetics in pregnancy

  Define population based pharmacokinetic model of aspirin in first trimester of pregnancy taking into consideration individual factors (gestational age, race, BMI, genotype)

  2 weeks

Secondary Outcomes (9)

• Aim 1: Aspirin response

  2 weeks

• Aim 1: Prediction of HDP

  8 months (delivery)

• Aim 1: First trimester serum thromboxane and risk of HDP

  8 months (delivery)

• Aim 1: Third trimester serum thromboxane and risk of HDP

  8 months (delivery)

• Aim 2: Pharmacogenomics and Pregnancy outcome

  8 months (delivery)

Study Arms (1)

Low Dose Aspirin

Pregnant singletons at high risk for preeclampsia based on: * at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, lupus, antiphospholipid antibody syndrome, or chronic kidney disease. OR * at least two of the following: BMI\>30, black race, state insurance, IVF pregnancy, advanced maternal age, nulliparous or \>10yr from last delivery, prior adverse pregnancy outcome who are planning to, but have not yet started, aspirin therapy \<16 weeks' gestation. Patients will take 81mg aspirin as prescribed.

Drug: Aspirin 81 mg

Interventions

Aspirin 81 mg DRUG

Aspirin 81mg daily PO

Low Dose Aspirin

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients at high risk for preeclampsia

You may qualify if:

• Pregnant singleton, \<16 weeks' gestation
• At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome

You may not qualify if:

• Contraindication to aspirin
• Current or planned use of any other anticoagulation
• Use of aspirin in pregnancy prior to enrollment
• Known platelet disorder at time of enrollment

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• March of Dimes: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples collected prospectively prior to aspirin initiation, after aspirin initation, and in the third trimester

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: March 5, 2020
• Study Start: August 21, 2020
• Primary Completion: November 18, 2022
• Study Completion: June 30, 2023
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)