Scientists hunt for hidden culprit behind dangerous pregnancy condition
NCT ID NCT04154332
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which drug best steadies blood pressure during C-Section in preeclampsia?
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