PreeclampsiaNCT04154332
Exosome Cargo From Preeclampsia Patients
An observational study of Preeclampsia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Sample collection
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 15 Dec 2031
- 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
- Healthy volunteers accepted
- Adult
Study population: Representative of the local population delivering at the university women and infant center.
Who may be able to join
- Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features:
- BP ≥160/110 after 20 weeks gestation AND ≥300 mg/day proteinuria or protein/creatinine ratio of 0.3 mg/dL; OR
- BP ≥160/110 after 20 weeks gestation with any of the following co-conditions: platelet count less than 100,000 X 109/L, AST/ALT enzymes elevated to twice the upper limit of normal, serum creatinine ≥1.1 mg/dL or a doubling of the creatinine from baseline, pulmonary edema, new-onset headache, and/or visual disturbances.
- Control patients: Age ≥ 18 years; no diagnosis of preeclampsia or any pregnancy-induced hypertension disorder.
- Pre-clampsia patients will be defined as =140 mmHg systolic or =90mmHg diastolic BP with at least at least 2 occasions 4 hours apart after 20 weeks of gestation in previously normotensive women with at least one of the following symptoms: =300 mg/day proteinuria, protein/creatinine ratio of 0.3 mg/dL, platelet count < 100,000 X 109/L, elevated liver enzymes, serum creatinine =1.1 mg/dL, pulmonary edema, or new-onset headache or visual disturbances.
- >22w 0d gestational age -33w 6d GA (n=16)
Show all 13Show fewer
- >= 34 wGA (n=16)
- Pre-eclampsia with severe features will be defined as blood pressure =160 mmHg systolic or =110 mmHg diastolic BP at least 2 occasions 4 hours apart after 20 weeks of gestation with any of the additional diagnostic criteria listed above.
- >22w 0d gestational age -33w 6d GA (n=16)
- >= 34 wGA (n=16)
- Healthy gestational age matched controls:
- >22w 0d gestational age -33w 6d GA (n=32)
- >= 34 wGA (n=32)
Who cannot join
- Preeclampsia patients: Age < 18 years; Any other diagnosis of pregnancy-induced hypertension that isn't preeclampsia with severe features (i.e. gestational hypertension or preeclampsia without severe features).
- Control Patients: Age < 18 years; Any diagnosis of pregnancy-induced hypertension.
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 Alabama at Birmingham
Birmingham, Alabama, 35233
Kera N Marshall, BS, 205-934-4042, Keramarshall@uabmc.edu
Ayesha Bryant, MD, MSPH, 205-934-4696, asbryant@uab.edu
About this study
Official title: Exosome Cargo From Preeclamptic Patients Mediates Endothelial Dysfunction, Subsequent Cardiovascular Remodeling, and the Preeclamptic Phenotype
Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in/ex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease.
Read the detailed description
Study Update: In evaluating the contents of the exosome cargo, we have discovered two important biomarkers - vasorin and angiotensin - are inversely correlated in preeclamptic vs. healthy patients. The angiotensin to vasorin (ANG/VASN) ratio is low in healthy patients vs. elevated in preeclamptic patients. We would like to extend this study to collect more samples in an effort to further explore this biomarker relationship in exosome cargo.
The device is the VENDYS-II device (Endothelix, Palo Alto, CA). It is a device approved by the FDA to measure vascular reactivity using non-invasive means. The way it detects vascular reactivity is by measuring the peripheral temperature changes in the finger pads of the index fingers before, during, and after arterial occlusion by a blood pressure cuff. A temperature sensor is placed on the finger pad of both the right and left index fingers. A baseline temperature is measured by the device for 5 minutes. Then, a blood pressure cuff will occlude arterial flow to the right arm for 5 minutes. Temperature differences in both index fingers will continue to be measured during this time. After 5 minutes, the cuff deflates, and the device will measure temperature changes in both fingers for a final 5 minutes (15 minutes total). Temperature differences during the ischemia-reperfusion time will be used to calculate the patient's vascular reactivity.
The device for its intended purpose as outlined by the FDA. It is non-invasive. The purpose of adding this device is to determine if there is a correlation in vascular dysfunction, as measured by the VENDYS-II device, with our exosome cargo values.
After the patient is consented and enrolled in the study, we will place the device on the patient. The device will be used as outlined by the FDA. Finger sensors will be placed on the pads of the index fingers. The blood pressure cuff will be placed on the arm. Baseline measurement by the device will occur for 5 minutes. After this time, the cuff will inflate and occlude arterial blood flow to one of the arms for 5 minutes. It will then deflate. Temperature measurement will occur for 5 more minutes. Patient participation time in this portion of the study will be 15 minutes. Data collected from the device will be securely stored on our HIPAA-compliant, password-protected research file. Date of birth is a required field for each patient on the device. When the data is extracted from the device, it will be de-identified and linked to the patient's samples only by the study identifier (i.e. C-1, C-2, PE-1, PE-2, etc.). As this device is non-invasive, there is minimal risk to the patient.
Risks include discomfort to the arm with the blood pressure cuff. This discomfort could be mild pain around the blood pressure cuff and numbness and tingling in the hand during cuff occlusion. There is also a risk for mild bruising around the cuff site.
- Conditions
- Preeclampsia
- Being tested
- Sample collection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Blood, urine, placental samples, and the patient's vascular reactivity will be collected from each person enrolled in this study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Not described Receives: Other: Sample collection | |
| Preeclampsia Group | Not described Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exosome cargo levels
Researchers and investigators will attempt to quantify the amount of exosome abnormalities that may be present among patient populations who exhibit the preeclampsia phenotype.
Measured: Through study completion, average of four hours of involvement time total, after informed consent discussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start2 Dec 2019
- Primary completion29 Jun 2030 (estimated)
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teshi Kaushik, University of Alabama at Birmingham
- Investigators
- Teshi Kaushik, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154332
- Sponsor's protocol ID
- IRB-300004235
- Other IDs
- UAB
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murugesan S, Hussey H, Saravanakumar L, Sinkey RG, Sturdivant AB, Powell MF, Berkowitz DE. Extracellular Vesicles From Women With Severe Preeclampsia Impair Vascular Endothelial Function. Anesth Analg. 2022 Apr 1;134(4):713-723. doi: 10.1213/ANE.0000000000005812.
PubMed 34871190
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome Cargo From Preeclamptic Patients Mediates Endothelial Dysfunction, Subsequent Cardiovascular Remodeling, and the Preeclamptic Phenotype
- ClinicalTrials.gov ID
- NCT04154332
- Acronym / sponsor ID
- IRB-300004235
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 29 Jun 2030 (estimated)
- Study completion
- 15 Dec 2031 (estimated)
- First posted
- 6 Nov 2019 (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.
Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in/ex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease.
Detailed description
Study Update: In evaluating the contents of the exosome cargo, we have discovered two important biomarkers - vasorin and angiotensin - are inversely correlated in preeclamptic vs. healthy patients. The angiotensin to vasorin (ANG/VASN) ratio is low in healthy patients vs. elevated in preeclamptic patients. We would like to extend this study to collect more samples in an effort to further explore this biomarker relationship in exosome cargo.
The device is the VENDYS-II device (Endothelix, Palo Alto, CA). It is a device approved by the FDA to measure vascular reactivity using non-invasive means. The way it detects vascular reactivity is by measuring the peripheral temperature changes in the finger pads of the index fingers before, during, and after arterial occlusion by a blood pressure cuff. A temperature sensor is placed on the finger pad of both the right and left index fingers. A baseline temperature is measured by the device for 5 minutes. Then, a blood pressure cuff will occlude arterial flow to the right arm for 5 minutes. Temperature differences in both index fingers will continue to be measured during this time. After 5 minutes, the cuff deflates, and the device will measure temperature changes in both fingers for a final 5 minutes (15 minutes total). Temperature differences during the ischemia-reperfusion time will be used to calculate the patient's vascular reactivity.
The device for its intended purpose as outlined by the FDA. It is non-invasive. The purpose of adding this device is to determine if there is a correlation in vascular dysfunction, as measured by the VENDYS-II device, with our exosome cargo values.
After the patient is consented and enrolled in the study, we will place the device on the patient. The device will be used as outlined by the FDA. Finger sensors will be placed on the pads of the index fingers. The blood pressure cuff will be placed on the arm. Baseline measurement by the device will occur for 5 minutes. After this time, the cuff will inflate and occlude arterial blood flow to one of the arms for 5 minutes. It will then deflate. Temperature measurement will occur for 5 more minutes. Patient participation time in this portion of the study will be 15 minutes. Data collected from the device will be securely stored on our HIPAA-compliant, password-protected research file. Date of birth is a required field for each patient on the device. When the data is extracted from the device, it will be de-identified and linked to the patient's samples only by the study identifier (i.e. C-1, C-2, PE-1, PE-2, etc.). As this device is non-invasive, there is minimal risk to the patient.
Risks include discomfort to the arm with the blood pressure cuff. This discomfort could be mild pain around the blood pressure cuff and numbness and tingling in the hand during cuff occlusion. There is also a risk for mild bruising around the cuff site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Sample collection |
| Preeclampsia Group | – | Other: Sample collection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Representative of the local population delivering at the university women and infant center.
Key inclusion criteria (13 listed)
- Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features:
- Control patients: Age ≥ 18 years; no diagnosis of preeclampsia or any pregnancy-induced hypertension disorder.
- Pre-clampsia patients will be defined as =140 mmHg systolic or =90mmHg diastolic BP with at least at least 2 occasions 4 hours apart after 20 weeks of gestation in previously normotensive women with at least one of the following symptoms: =300 mg/day proteinuria, protein/creatinine ratio of 0.3 mg/dL, platelet count < 100,000 X 109/L, elevated liver enzymes, serum creatinine =1.1 mg/dL, pulmonary edema, or new-onset headache or visual disturbances.
- Pre-eclampsia with severe features will be defined as blood pressure =160 mmHg systolic or =110 mmHg diastolic BP at least 2 occasions 4 hours apart after 20 weeks of gestation with any of the additional diagnostic criteria listed above.
- Healthy gestational age matched controls:
Key exclusion criteria (2 listed)
- Preeclampsia patients: Age < 18 years; Any other diagnosis of pregnancy-induced hypertension that isn't preeclampsia with severe features (i.e. gestational hypertension or preeclampsia without severe features).
- Control Patients: Age < 18 years; Any diagnosis of pregnancy-induced hypertension.
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 |
|---|---|---|
| Sample collectionBlood, urine, placental samples, and the patient's vascular reactivity will be collected from each person enrolled in this study. | Other | Healthy Controls, Preeclampsia Group |
Primary outcome
Exosome cargo levels
Time frame: Through study completion, average of four hours of involvement time total, after informed consent discussion
Researchers and investigators will attempt to quantify the amount of exosome abnormalities that may be present among patient populations who exhibit the preeclampsia phenotype.
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 7 Jul 2026.
- Derived from this study: PubMed 34871190Murugesan S, Hussey H, Saravanakumar L, Sinkey RG, Sturdivant AB, Powell MF, Berkowitz DE. Extracellular Vesicles From Women With Severe Preeclampsia Impair Vascular Endothelial Function. Anesth Analg. 2022 Apr 1;134(4):713-723. doi: 10.1213/ANE.0000000000005812.
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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.
Teshi Kaushik, MD principal investigator
University of Alabama at Birmingham
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 University of Alabama at Birmingham 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 13 inclusion and 2 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 7 Jul 2026. 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 Shanna H Graves (205-975-2845, shannagraves@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exosome cargo levels (time frame: Through study completion, average of four hours of involvement time total, after informed consent discussion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154332, which also lists 1 linked publication.
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 7 Jul 2026.