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Scientists hunt for hidden culprit behind dangerous pregnancy condition

NCT ID NCT04154332

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First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study aims to understand how tiny particles called exosomes, released from the placenta, may cause preeclampsia—a serious pregnancy condition involving high blood pressure. Researchers will collect blood and placenta samples from 64 women with preeclampsia and study these particles in the lab and in animals. The goal is to uncover the root causes of the disease and find new ways to treat it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Representative of the local population delivering at the university women and infant center.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

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Contacts and locations

Locations

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

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