Exosome Cargo From Preeclampsia Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04154332
Status
Recruiting
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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 2, 2019
Status verified
Jan 2026
Primary completion
Jun 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
64 participants (estimated)

Arms

  • Arm: Healthy Controls
  • Arm: Preeclampsia Group

Primary Outcome Measure

Exosome cargo levels [ Time Frame: Through study completion, average of four hours of involvement time total, after informed consent discussion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Kera N Marshall, BS
[email protected]
205-934-4042
Ayesha Bryant, MD, MSPH
[email protected]
205-934-4696
Michelle Tubinis, MD (PRINCIPAL_INVESTIGATOR)

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