Investigating exosome cargo in patients with preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the role of exosomes released from the placenta in the development of preeclampsia by isolating them from maternal blood and placental tissue. Researchers will analyze the biochemical, cellular, and molecular mechanisms of these exosomes in an animal model to understand their impact on preeclampsia and cardiovascular changes. The study will also investigate specific biomarkers, such as vasorin and angiotensin, to further elucidate their relationship in preeclamptic patients compared to healthy controls. Patient samples will be collected from volunteers delivering at the Women and Infants Center for detailed laboratory analysis.

Why it matters

Who can join: the full rules

Inclusion

1. Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features:

   1. BP ≥160/110 after 20 weeks gestation AND ≥300 mg/day proteinuria or protein/creatinine ratio of 0.3 mg/dL; OR
   2. 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.
3. 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.

   1. \>22w 0d gestational age -33w 6d GA (n=16)
   2. \>= 34 wGA (n=16)
4. 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.

   1. \>22w 0d gestational age -33w 6d GA (n=16)
   2. \>= 34 wGA (n=16)
5. Healthy gestational age matched controls:

   1. \>22w 0d gestational age -33w 6d GA (n=32)
   2. \>= 34 wGA (n=32)

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Teshi Kaushik, MD — University of Alabama at Birmingham
• Study coordinator: Shanna H Graves
• Email: shannagraves@uabmc.edu
• Phone: 205-975-2845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.