Exosome Cargo From Preeclampsia Patients

Recruiting

• Conditions: Preeclampsia

• Registration Number: NCT04154332
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion<br><br> 1. Preeclampsia patients: Age = 18 years; Diagnosis of preeclampsia with severe<br> features:<br><br> 1. BP =160/110 after 20 weeks gestation AND =300 mg/day proteinuria or<br> protein/creatinine ratio of 0.3 mg/dL; OR<br><br> 2. BP =160/110 after 20 weeks gestation with any of the following co-conditions:<br> platelet count less than 100,000 X 109/L, AST/ALT enzymes elevated to twice the<br> upper limit of normal, serum creatinine =1.1 mg/dL or a doubling of the<br> creatinine from baseline, pulmonary edema, new-onset headache, and/or visual<br> disturbances.<br><br> 2. Control patients: Age = 18 years; no diagnosis of preeclampsia or any<br> pregnancy-induced hypertension disorder.<br><br> 3. Pre-clampsia patients will be defined as =140 mmHg systolic or =90mmHg diastolic BP<br> with at least at least 2 occasions 4 hours apart after 20 weeks of gestation in<br> previously normotensive women with at least one of the following symptoms: =300<br> mg/day proteinuria, protein/creatinine ratio of 0.3 mg/dL, platelet count < 100,000<br> X 109/L, elevated liver enzymes, serum creatinine =1.1 mg/dL, pulmonary edema, or<br> new-onset headache or visual disturbances.<br><br> 1. >22w 0d gestational age -33w 6d GA (n=16)<br><br> 2. >= 34 wGA (n=16)<br><br> 4. Pre-eclampsia with severe features will be defined as blood pressure =160 mmHg<br> systolic or =110 mmHg diastolic BP at least 2 occasions 4 hours apart after 20 weeks<br> of gestation with any of the additional diagnostic criteria listed above.<br><br> 1. >22w 0d gestational age -33w 6d GA (n=16)<br><br> 2. >= 34 wGA (n=16)<br><br> 5. Healthy gestational age matched controls:<br><br> 1. >22w 0d gestational age -33w 6d GA (n=32)<br><br> 2. >= 34 wGA (n=32)<br><br>Exclusion criteria:<br><br> 1. Preeclampsia patients: Age < 18 years; Any other diagnosis of pregnancy-induced<br> hypertension that isn't preeclampsia with severe features (i.e. gestational<br> hypertension or preeclampsia without severe features).<br><br> 2. Control Patients: Age < 18 years; Any diagnosis of pregnancy-induced hypertension.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exosome cargo levels