PreeclampsiaAPROACHNCT04295850
Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)
An observational study of Preeclampsia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. Read more about this study
- Who is it for?
- Ages 10 to 60 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin 81 mg
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant patients at high risk for preeclampsia
Who may be able to join
- Pregnant singleton, <16 weeks' gestation
- At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome
Who cannot join
- Contraindication to aspirin
- Current or planned use of any other anticoagulation
- Use of aspirin in pregnancy prior to enrollment
- Known platelet disorder at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.
Read the detailed description
This proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of HDP through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.
Aim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.
Aim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.
Aim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.
Aim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin
- Conditions
- Preeclampsia
- Being tested
- Aspirin 81 mg
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mgDrug
Aspirin 81mg daily PO
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Aspirin | Pregnant singletons at high risk for preeclampsia based on:
* at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, lupus, antiphospholipid antibody syndrome, or chronic kidney disease. OR
* at least two of the following: BMI>30, black race, state insurance, IVF pregnancy, advanced maternal age, nulliparous or >10yr from last delivery, prior adverse pregnancy outcome
who are planning to, but have not yet started, aspirin therapy <16 weeks' gestation. Patients will take 81mg aspirin as prescribed. Receives: Drug: Aspirin 81 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP)
Difference in first trimester PFA-100 closure time between patients started on aspirin who do and do not develop HDP
Measured: 8 months (delivery)
Aim 2: Pharmacogenomics of aspirin
Difference in PFA-100 closure time with aspirin therapy based on platelet receptor genotype
Measured: 2 weeks
Aim 3: MicroRNAs and HDP
Regression analysis to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels in first trimester are associated with risk of HDP
Measured: 8 months (delivery)
Aim 4: Aspirin pharmacokinetics in pregnancy
Define population based pharmacokinetic model of aspirin in first trimester of pregnancy taking into consideration individual factors (gestational age, race, BMI, genotype)
Measured: 2 weeks
Secondary outcomes (9)
Aim 1: Aspirin response
Multiple logisitic regression analysis to evaluate factors (BMI, race, gestational age, genotype) associated with rate of nonresponse to aspirin therapy defined as (PFA-100>150s)
Measured: 2 weeks
Aim 1: Prediction of HDP
ROCC curve to determine threshold PFA-100 closure time after 1 week of aspirin therapy that is predictive of HDP
Measured: 8 months (delivery)
Aim 1: First trimester serum thromboxane and risk of HDP
Comparison between first trimester serum thromboxane in those with and without hypertensive disorder of pregnancy
Measured: 8 months (delivery)
Aim 1: Third trimester serum thromboxane and risk of HDP
Comparison between third trimester serum thromboxane in those with and without hypertensive disorder of pregnancy
Measured: 8 months (delivery)
Aim 2: Pharmacogenomics and Pregnancy outcome
Multiple regression analysis taking into consideration platelet receptor genotype, race, BMI, and other clinical characteristics and prediction of HDP
Measured: 8 months (delivery)
Aim 3: MicroRNA profile and aspirin therapy
Paired comparison to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels change before and after aspirin therapy
Measured: 2 weeks
Aim 4: Salicylic acid level and Serum Thromboxane
Association between serum salicylic acid with aspirin therapy and serum thromboxane with aspirin therapy
Measured: 2 weeks
Predictors of preterm birth
Multivariable logistic regression to evaluate markers predictive of preterm birth
Measured: 8 months (delivery)
Predictors of preeclampsia
Multivariable logistic regression to evaluate markers predictive of preeclampsia and preterm preeclampsia
Measured: 8 months (delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start21 Aug 2020
- Primary completion18 Nov 2022
- Study completion30 Jun 2023
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.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295850
- Sponsor's protocol ID
- 19F.887
- Other IDs
- R21HD101127
- Acronym
- APROACH
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared upon individual request after publication of planned analyses
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)
- ClinicalTrials.gov ID
- NCT04295850
- Acronym / sponsor ID
- APROACH / 19F.887
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March of Dimes
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Mar 2020 (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 proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.
Detailed description
This proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of HDP through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.
Aim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.
Aim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.
Aim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.
Aim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose Aspirin | – | Drug: Aspirin 81 mgPregnant singletons at high risk for preeclampsia based on: * at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, lupus, antiphospholipid antibody syndrome, or chronic kidney disease. OR * at least two of the following: BMI>30, black race, state insurance, IVF pregnancy, advanced maternal age, nulliparous or >10yr from last delivery, prior adverse pregnancy outcome who are planning to, but have not yet started, aspirin therapy <16 weeks' gestation. Patients will take 81mg aspirin as prescribed. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant patients at high risk for preeclampsia
Key inclusion criteria (2 listed)
- Pregnant singleton, <16 weeks' gestation
- At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome
Key exclusion criteria (4 listed)
- Contraindication to aspirin
- Current or planned use of any other anticoagulation
- Use of aspirin in pregnancy prior to enrollment
- Known platelet disorder at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81 mgAspirin 81mg daily PO | Drug | Low Dose Aspirin |
Primary outcome
Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP)
Time frame: 8 months (delivery)
Difference in first trimester PFA-100 closure time between patients started on aspirin who do and do not develop HDP
Aim 2: Pharmacogenomics of aspirin
Time frame: 2 weeks
Difference in PFA-100 closure time with aspirin therapy based on platelet receptor genotype
Aim 3: MicroRNAs and HDP
Time frame: 8 months (delivery)
Regression analysis to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels in first trimester are associated with risk of HDP
Aim 4: Aspirin pharmacokinetics in pregnancy
Time frame: 2 weeks
Define population based pharmacokinetic model of aspirin in first trimester of pregnancy taking into consideration individual factors (gestational age, race, BMI, genotype)
9 secondary outcomes
Aim 1: Aspirin response
Time frame: 2 weeks
Aim 1: Prediction of HDP
Time frame: 8 months (delivery)
Aim 1: First trimester serum thromboxane and risk of HDP
Time frame: 8 months (delivery)
Aim 1: Third trimester serum thromboxane and risk of HDP
Time frame: 8 months (delivery)
Aim 2: Pharmacogenomics and Pregnancy outcome
Time frame: 8 months (delivery)
Aim 3: MicroRNA profile and aspirin therapy
Time frame: 2 weeks
Aim 4: Salicylic acid level and Serum Thromboxane
Time frame: 2 weeks
Predictors of preterm birth
Time frame: 8 months (delivery)
Predictors of preeclampsia
Time frame: 8 months (delivery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided. IPD may be shared upon individual request after publication of planned analyses
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Thomas Jefferson University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP) (time frame: 8 months (delivery)). The study lists 4 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 2 Dec 2025.