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

September 3, 2025 updated by: University of Tennessee Graduate School of Medicine
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant individuals at risk for preeclampsia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pregnant individuals at risk for preecampsia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hexadecadienoate (z score)
Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Salicylate (z score)
Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Urinary thromboxane B2 level (pg/mg creat)
60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age
Fasting Salicylate level (ug/mL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting Salicylate level (ug/mL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour Salicylate level (ug/mL)
Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
1 Hour Salicylate level (ug/mL) in venous blood
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2 Hour Salicylate level (ug/mL)
Time Frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2 Hour Salicylate level (ug/mL) in venous blood
120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Fasting PFA-100 epinephrine closure time
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting PFA-100 epinephrine closure time in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour PFA-100 epinephrine closure time
Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
1 Hour PFA-100 epinephrine closure time in venous blood
60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2 Hour PFA-100 epinephrine closure time
Time Frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2 Hour PFA-100 epinephrine closure time in venous blood
120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Homeostatic Model Assessment for Insulin Resistance
Time Frame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age
Approximates insulin resistance.
Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age
Fasting Resting Metabolic Rate
Time Frame: Measured at the start of a single study visit between 14-20 weeks gestational age
Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Respiratory Quotient
Time Frame: Measured at the start of a single study visit between 14-20 weeks gestational age
Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Carbohydrate Oxidation Rate
Time Frame: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Lipid Oxidation Rate
Time Frame: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Insulin (mIU/mL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting insulin level (mIU/mL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting glucose (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting glucose level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting lactate (mmol/L)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting lactate level (mmol/L) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting triglycerides (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting triglycerides level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting high density lipoprotein (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting very low density lipoprotein (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting low density lipoprotein (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting cholesterol (mg/dL)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting cholesterol level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting free fatty acids (mEq/L)
Time Frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting free fatty acids (FFA) (mEq/L) in venous blood
Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tennessee Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Reasonable requests will be considered on a case-by-case basis.

IPD Sharing Time Frame

We anticipate publishing the study protocol within the next 2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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