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Dose based aspirin pharmacokinetics and pharmacodynamics in pregnancy and association with pregnancy outcomes

Award Number: R01HD112076
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/13/2025
PERIOD OF PERFORMANCE END DATE: 12/31/2029

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Dose based aspirin pharmacokinetics and pharmacodynamics in pregnancy and association with pregnancy outcomes - PROJECT SUMMARY Background: Aspirin is recommended in high risk pregnancies to reduce the risk of preeclampsia and preterm birth, but up to 20% will still have these adverse outcomes. Recommendations for aspirin dose range from 75mg-162mg daily. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and relationship between aspirin response and pregnancy outcome limit optimal use of aspirin to prevent adverse perinatal outcomes. Objective: 1) Determine platelet inhibition in response to increased dosing of aspirin through gestation and factors impacting aspirin response. 2) Determine aspirin population pharmacokinetics (PK) and PK/PD (pharmacodynamic) relationship through gestation. 3) Determine association between aspirin response and perinatal outcomes. Methods: This is a randomized controlled trial of N=300 high risk singleton pregnancies randomized to either 81mg BID or 162mg daily of aspirin, initiated <16 weeks, and continued until 36 weeks gestation. Participants will have aspirin response assessed at baseline, 2-4 weeks after aspirin initiation and at 28-32 weeks gestation. Aspirin response will be assessed with PFA-100 epinephrine closure time (primary) and urine and serum thromboxane (secondary). A subset (N=50) will be enrolled in a PK study that involves 8-hour study visits in the 1st and 3rd trimester. Expected Results: Analyses for aims will include the two arms of the randomized trial along with a third arm of N=96 high risk singletons who took 81mg aspirin daily (already complete). Aim 1 will compare aspirin response between dosing groups and identify individual covariates that impact aspirin response. Aim 2 will develop a pregnancy model for aspirin PK and PK/PD. Aim 3 will examine the relationship between aspirin response and perinatal outcomes Impact: 1) Novel paradigm in clinical care, adjusting aspirin dosing based not only on the risk for preeclampsia/preterm birth, as currently suggested, but also on anticipated response to aspirin in pregnancy based on individual factors. 2) Inform development of a novel clinical paradigm with use of aspirin response to predict preterm birth, identifying patients who may benefit from dosing adjustment, adjunctive therapies, or additional monitoring. 3) Inform future clinical trials through computational modeling for rationale aspirin dose selection. 4) Inform novel research pathways of antiplatelet therapies in pregnancy through identification of relevant pharmacodynamic markers, individual covariates, and placental mechanisms of action. Ultimately, we will improve the management of high-risk pregnancies, leading to healthier mothers and babies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $663,370 )
2026	2026	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	001	2	4/1/2026	NON-COMPETING CONTINUATION	$66,336
2026	2026	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	2	12/30/2025	NON-COMPETING CONTINUATION	$597,034
														Subtotal = $663,370

Issue Date FY: 2025 ( Subtotal = $678,809 )
2025	2025	THOMAS JEFFERSON UNIVERSITY	1020 WALNUT ST STE 1	PHILADELPHIA	PA	19107	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	1	1/13/2025	NEW	$678,809
														Subtotal = $678,809

Grand Total All Awards = $1,342,179

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Dose based aspirin pharmacokinetics and pharmacodynamics in pregnancy and association with pregnancy outcomes

Award Number: R01HD112076

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/13/2025

PERIOD OF PERFORMANCE END DATE: 12/31/2029

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