Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery
Recruiting · NCT05675969 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Bordeaux
View the official record on ClinicalTrials.gov →Interventions studied
Blood sample
What this trial is about
A large number of studies on MVs from syncytiotrophoblasts support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory and anti-angiogenic factors. The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- CHU Bordeaux - Bordeaux, France