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

ConditionsPreeclampsiaPreeclampsia (PE)Preeclampsia (PE) RiskObesity and Obesity-related Medical ConditionsPregnancyPregnancy ComplicationsGestational DiabetesGestational Diabetes Mellitus in PregnancyGestational Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial population

Pregnant individuals at risk for preeclampsia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Pregnant individuals at risk for preecampsia

Trial outcomes

Primary outcomes

1

Hexadecadienoate (z score)

Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)

Time frame
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2

Salicylate (z score)

Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)

Time frame
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

Secondary outcomes

1

Urinary thromboxane B2 level (pg/mg creat)

Urinary thromboxane B2 level (pg/mg creat)

Time frame
60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age
2

Fasting Salicylate level (ug/mL)

Fasting Salicylate level (ug/mL) in venous blood

Time frame
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
3

1 Hour Salicylate level (ug/mL)

1 Hour Salicylate level (ug/mL) in venous blood

Time frame
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
4

2 Hour Salicylate level (ug/mL)

2 Hour Salicylate level (ug/mL) in venous blood

Time frame
120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee Graduate School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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