Exosome Cargo From Preeclampsia Patients

NCT04154332 | Recruiting DMC

• 2 other identifiers: IRB-300004235UAB
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, average of four hours of involvement time total, after informed consent discussion

Study Arms (2)

Healthy Controls

Other: Sample collection

Preeclampsia Group

Other: Sample collection

Interventions

Sample collection OTHER

Blood, urine, placental samples, and the patient's vascular reactivity will be collected from each person enrolled in this study.

Healthy Controls; Preeclampsia Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Representative of the local population delivering at the university women and infant center.

You may qualify if:

• 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)
• \>= 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34871190 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and placental tissue samples will be collected from each subject enrolled.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Teshi Kaushik, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanna H Graves

CONTACT

205-975-2845; shannagraves@uabmc.edu

Ayesha Bryant, MD, MSPH

CONTACT

205-934-4696; Asbryant@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 6, 2019
• Study Start: December 2, 2019
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)