Autophagy/Apoptosis Balance in Placental Vascular Pathologies
NCT ID: NCT06779916
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-05-02
2027-05-01
Brief Summary
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Deregulated autophagy could be the starting point for cell death by apoptosis or necrosis leading to complications.
The pathophysiological mechanisms involved in trophoblast apoptosis are incompletely described. This project follows on from the GrossAuTop-1 study, which investigated the intra- and inter-individual variability of autophagy and apoptosis activities in women during pregnancy. The aim of this project is to study autophagy and apoptosis activities specifically in women developing a placental vascular complication during pregnancy.
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Detailed Description
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Autophagy enables cell development, differentiation and survival, but if deregulated, it could be the starting point for cell death by apoptosis or necrosis, and promote the development of complications.
The pathophysiological mechanisms involved in trophoblast apoptosis are incompletely described. A deregulation of the trophoblast proliferation/cell death balance could be at the origin of placental pathologies. The regulation of autophagy and autophagy-dependent events during pregnancy have not been fully identified.
We hypothesize that there is an intratrophoblastic dialogue between autophagy and apoptosis mechanisms, with the promotion of one partially inhibiting the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an anti-apoptosis defense phenomenon, whose depletion would lead to cellular apoptosis and pathogenic consequences when it devastates the syncytiotrophoblast.
This project follows on from the GrossAuTop-1 study, which investigated the intra- and inter-individual variability of autophagy and apoptosis activities in women during pregnancy: the inclusions corresponded to all-pregnant women, the majority of whom developed a normal pregnancy. The aim of this project is to study autophagy and apoptosis activities specifically in women developing a placental vascular complication during pregnancy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women developing placental vascular complications
Pregnant adult women developing placental vascular complications such as preeclampsia and/or intrauterine growth retardation, hospitalized and delivering at Nimes University Hospital.
Blood test
16 blood samples (16 tubes, i.e. 55.3 ml) will be taken at inclusion. Pregnant women will be seen every month as part of their pregnancy follow-up, and blood (11 tubes, i.e. 35.5 ml) and urine samples will be taken at each follow-up visit.
At delivery, a systematic blood sample will be taken as part of the usual care, and an additional 11 tubes of blood (35.5 ml) will be taken.
Urine test
Urine samples will be taken at the inclusion visit and at each follow-up visit.
Interventions
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Blood test
16 blood samples (16 tubes, i.e. 55.3 ml) will be taken at inclusion. Pregnant women will be seen every month as part of their pregnancy follow-up, and blood (11 tubes, i.e. 35.5 ml) and urine samples will be taken at each follow-up visit.
At delivery, a systematic blood sample will be taken as part of the usual care, and an additional 11 tubes of blood (35.5 ml) will be taken.
Urine test
Urine samples will be taken at the inclusion visit and at each follow-up visit.
Eligibility Criteria
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Inclusion Criteria
* Pregnant woman with free and informed consent.
* Pregnant woman affiliated with and/or benefiting from a health insurance scheme.
Exclusion Criteria
* Presence of hypertension and/or proteinuria prior to pregnancy.
* Participant in an interventional drug study.
* Persons in a period of exclusion determined by another study.
* Persons under court protection, guardianship or curatorship.
* Persons unable to give consent.
* Persons for whom it is impossible to give informed information.
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Marie PORTES, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Mathieu FORTIER, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Jean-Christophe GRIS, Pr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Eve MOUSTY, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Vincent LETOUZEY, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Stéphanie HUBERLANT, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Chloé BOURGUIGNON, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Locations
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Nimes University Hospital
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIMAO/2024-1/SB01
Identifier Type: -
Identifier Source: org_study_id
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