Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exosome Cargo From Preeclampsia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154332
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Powell, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Preeclampsia Other: Sample collection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exosome Cargo From Preeclamptic Patients Mediates Endothelial Dysfunction, Subsequent Cardiovascular Remodeling, and the Preeclamptic Phenotype
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Controls Other: Sample collection
Blood, urine, and placental samples will be collected from each person enrolled in this study.

Preeclampsia Group Other: Sample collection
Blood, urine, and placental samples will be collected from each person enrolled in this study.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood, urine, and placental tissue samples will be collected from each subject enrolled.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Representative of the local population delivering at the university women and infant center.
Criteria

Inclusion

  1. Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features: (a) BP ≥160/110 after 20 weeks gestation AND ≥300 mg/day proteinuria or protein/creatinine ratio of 0.3 mg/dL; OR (b) 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.
  2. Control patients: Age ≥ 18 years; no diagnosis of preeclampsia or any pregnancy-induced hypertension disorder.

Exclusion criteria:

  1. 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).
  2. Control Patients: Age < 18 years; Any diagnosis of pregnancy-induced hypertension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154332


Contacts
Layout table for location contacts
Contact: Adam B Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu
Contact: Ayesha Bryant, MD, MSPH 205-934-4696 Asbryant@uabmc.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Mark F Powell, MD University of Alabama at Birmingham
Layout table for additonal information
Responsible Party: Mark Powell, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04154332    
Other Study ID Numbers: IRB-300004235
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications