Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

NCT ID: NCT04645004

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2024-03-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Preeclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One arm PK/PD study of aspirin in pregnancy1
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Aspirin

81mg aspirin daily

Group Type OTHER

Aspirin 81Mg Non-enteric coated Tab

Intervention Type DRUG

one tab daily

Interventions

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Aspirin 81Mg Non-enteric coated Tab

one tab daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

March of Dimes

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rupsa C Boelig, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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3R21HD101127-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20F.911

Identifier Type: -

Identifier Source: org_study_id

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