Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Preeclampsia Clinical Trial

— APROACH-PK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645004
• Other study ID #: 20F.911
• Secondary ID: 3R21HD101127-01S
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 29, 2020
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 15, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Aspirin 81Mg Non-enteric coated Tab
one tab daily

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salicylic acid level	time/concentration profile	24 hour
Primary	serum thromboxane	ELISA based quantification of serum thromboxane B2	4 week post initiation
Primary	PFA-100	PFA-100 epi closure time (Siemens)	4 week post initiation
Secondary	Urinary thromboxane	ELISA based quantification of urindary dehydrothromboxane B2	4 week post initiation