PreeclampsiaRAMPNCT06802861
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
An observational study of Preeclampsia and Preeclampsia (PE), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant individuals at risk for preeclampsia
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Rebecca Purvis, MD, rpurvis@utmck.edu
About this study
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.
- Conditions
- Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications
- Keywords
- metabolic dysfunction, gestational diabetes, pregnancy, maternal obesity, maternal insulin resistance, aspirin metabolism, GDM, substrate oxidation, gestational glucose intolerance
- Medical subject headings
- Pre-Eclampsia, Obesity, Pregnancy Complications, Diabetes, Gestational, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant individuals at risk for preecampsia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hexadecadienoate (z score)
Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)
Measured: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Salicylate (z score)
Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)
Measured: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Secondary outcomes (21)
Urinary thromboxane B2 level (pg/mg creat)
Urinary thromboxane B2 level (pg/mg creat)
Measured: 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)
Fasting Salicylate level (ug/mL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour Salicylate level (ug/mL)
1 Hour Salicylate level (ug/mL) in venous blood
Measured: 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)
2 Hour Salicylate level (ug/mL) in venous blood
Measured: 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
Fasting PFA-100 epinephrine closure time in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour PFA-100 epinephrine closure time
1 Hour PFA-100 epinephrine closure time in venous blood
Measured: 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
2 Hour PFA-100 epinephrine closure time in venous blood
Measured: 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
Approximates insulin resistance.
Measured: 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
Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Respiratory Quotient
Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Carbohydrate Oxidation Rate
Fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Lipid Oxidation Rate
Fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Insulin (mIU/mL)
Fasting insulin level (mIU/mL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting glucose (mg/dL)
Fasting glucose level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting lactate (mmol/L)
Fasting lactate level (mmol/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting triglycerides (mg/dL)
Fasting triglycerides level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting high density lipoprotein (mg/dL)
Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting very low density lipoprotein (mg/dL)
Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting low density lipoprotein (mg/dL)
Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting cholesterol (mg/dL)
Fasting cholesterol level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting free fatty acids (mEq/L)
Fasting free fatty acids (FFA) (mEq/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802861
- Sponsor's protocol ID
- 5316
- Acronym
- RAMP
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reasonable requests will be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
- ClinicalTrials.gov ID
- NCT06802861
- Acronym / sponsor ID
- RAMP / 5316
- Conditions
- Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications
- Keywords
- metabolic dysfunction, gestational diabetes, pregnancy, maternal obesity, maternal insulin resistance, aspirin metabolism, GDM, substrate oxidation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant individuals at risk for preecampsia | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant individuals at risk for preeclampsia
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- Type 2 Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
21 secondary outcomes
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
Fasting Salicylate level (ug/mL)
Time frame: 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
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
Fasting PFA-100 epinephrine closure time
Time frame: 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
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
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
Fasting Resting Metabolic Rate
Time frame: 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
Fasting Carbohydrate Oxidation Rate
Time frame: 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 Insulin (mIU/mL)
Time frame: 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 lactate (mmol/L)
Time frame: 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 high 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 (mg/dL)
Time frame: 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 cholesterol (mg/dL)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. Reasonable requests will be considered on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Preeclampsia (PE), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill M Maples, PhD (865-305-9367, jmaples1@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.