Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm… (NCT05675969) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery
France20 participantsStarted 2023-05-31
Plain-language summary
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 participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.