Exosome Cargo From Preeclampsia Patients

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Nov 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the role of tiny particles called exosomes that are released from the placenta in women with a condition called preeclampsia. Preeclampsia is a serious pregnancy complication characterized by high blood pressure and can lead to health problems for both the mother and baby. The researchers will collect blood and tissue samples from women diagnosed with preeclampsia, as well as from healthy pregnant women, to understand how these exosomes might contribute to the disease. By analyzing these samples in a laboratory setting, the team hopes to uncover important information that could lead to new treatments for preeclampsia and related heart issues.

To be eligible for this study, participants must be women aged 18 or older who have been diagnosed with severe preeclampsia, which is defined by very high blood pressure and other specific health concerns. Healthy pregnant women without any pregnancy-related high blood pressure issues can also participate. Participants can expect to provide samples that will help researchers learn more about the disease and its effects. The study is currently recruiting participants, and the findings may lead to better understanding and management of preeclampsia in the future.

Gender

FEMALE

Eligibility criteria

• • 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.