Comparing microvesicles in pregnant women with and without pre-eclampsia
Study of Microvesicles in Pre-eclampsia
This study is testing if the tiny particles in the blood of pregnant women can help tell the difference between those with severe pre-eclampsia and those without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05675969 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the concentration of microvesicles in the blood of pregnant women diagnosed with severe pre-eclampsia compared to those without the condition. Microvesicles are membrane fragments released by cells that may serve as biomarkers for various conditions, including pre-eclampsia. The research will utilize advanced techniques such as cryo-electron microscopy and flow cytometry to characterize and quantify these microvesicles. The goal is to better understand the role of microvesicles in pre-eclampsia and their potential as indicators of maternal health during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 and older, between 23 and 31+6 weeks of gestation, with either a diagnosis of severe pre-eclampsia or those hospitalized for isolated threat of preterm delivery without inflammation.
Not a fit: Patients who are unable to provide informed consent or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for early detection of pre-eclampsia, enhancing maternal and fetal health outcomes.
How similar studies have performed: Previous studies have indicated the potential of microvesicles as biomarkers in pre-eclampsia, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Singleton pregnancy (or spontaneously reduced twin pregnancy before 14 SA) * Gestational age at inclusion between 23 and 31+6 SA * Collection of the patient's non-opposition * Affiliated or beneficiary of a social security system * Specifically for the non-pre-eclampsia group: non-pre-eclamptic patient hospitalized for isolated threat of preterm delivery, whatever the origin, and without clinical (absence of maternal hyperthermia defined by a maternal temperature \< 38.0°C) or biological markers of inflammation (CRP\<5) * Specifically for the pre-eclampsia group : diagnosis of severe pre-eclampsia before 32 weeks' gestation Exclusion Criteria: * Patient's inability to understand the nature, risks, meaning and implications of the clinical investigation or refusal to give consent * Patient under legal protection.
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Loic Sentilhes, MD, PhD
- Email: loic.sentilhes@chu-bordeaux.fr
- Phone: +335 57 82 23 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.