Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

NCT ID: NCT06802861

Last Updated: 2025-09-10

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-12-31

Brief Summary

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This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

Detailed Description

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Conditions

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Preeclampsia Preeclampsia (PE) Preeclampsia (PE) Risk Obesity and Obesity-related Medical Conditions Pregnancy Pregnancy Complications Gestational Diabetes Gestational Diabetes Mellitus in Pregnancy Gestational Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant individuals at risk for preecampsia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors)

* Willingness to adhere to aspirin therapy
* Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
* Gestational age at enrollment \<16 weeks
* Ability to speak, read, and communicate via English

Exclusion Criteria

* Type 2 Diabetes Mellitus

* Type 1 Diabetes Mellitus
* Current gestational diabetes mellitus
* Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
* Thrombophilia
* Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
* Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
* Current or recent use of steroids
* Current use of prophylactic or therapeutic anticoagulation
* Medical contraindication to aspirin therapy
* Molar pregnancy
* Renal disease
* Inability or unwillingness to give informed consent
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jill M Maples, PhD

Role: CONTACT

865-305-9367

Facility Contacts

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Rebecca Purvis, MD

Role: primary

Other Identifiers

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5316

Identifier Type: -

Identifier Source: org_study_id

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