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Completed

NCT Number: NCT04645004

Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

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

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

13 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 81Mg Non-enteric coated Tab

Drug

one tab daily

Primary outcomes

  1. salicylic acid level

    Time frame: 24 hour

    time/concentration profile

  2. serum thromboxane

    Time frame: 4 week post initiation

    ELISA based quantification of serum thromboxane B2

  3. PFA-100

    Time frame: 4 week post initiation

    PFA-100 epi closure time (Siemens)

Secondary outcomes

  1. Urinary thromboxane

    Time frame: 4 week post initiation

    ELISA based quantification of urindary dehydrothromboxane B2

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: APROACH-PK

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2020
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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