Autophagy/Apoptosis Balance in Placental Vascular Pathologies

NCT ID: NCT06779916

Last Updated: 2025-11-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-02

Study Completion Date

2027-05-01

Brief Summary

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Pregnancy increases the risk of thrombosis. Placenta-mediated diseases are a risk factor for cardiovascular pathologies and can lead to maternal-fetal morbidity and mortality. It is essential to understand the cellular and molecular mechanisms of dysfunctions at the vascular-placental interface so that systemic vascular risk can be characterized and, ultimately, screened for, on the basis of new markers (targeted preventive management).

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.

Detailed Description

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Pregnancy increases the risk of thrombosis. Diseases mediated by the placenta are a risk factor for cardiovascular pathologies. They are responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions at the vascular-placental interface could provide arguments for understanding systemic vascular risk, characterizing it and ultimately screening for it on the basis of new markers, thus paving the way for targeted preventive management, feeding into the general principle of precision medicine.

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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Pregnancy Complications Pre-Eclampsia Growth Retardation, Intrauterine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_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.

Intervention Type DIAGNOSTIC_TEST

Urine test

Urine samples will be taken at the inclusion visit and at each follow-up visit.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pregnant women developing a placental vascular complication (preeclampsia and/or intrauterine growth retardation), hospitalized and delivering at Nimes University Hospital.
* Pregnant woman with free and informed consent.
* Pregnant woman affiliated with and/or benefiting from a health insurance scheme.

Exclusion Criteria

* Multiple pregnancy.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvie BOUVIER, Dr.

Role: CONTACT

+334.66.68.32.11

Anissa MEGZARI

Role: CONTACT

+334 66 68 42 36

Facility Contacts

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sylvie bouvier

Role: primary

0466686868

Other Identifiers

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NIMAO/2024-1/SB01

Identifier Type: -

Identifier Source: org_study_id

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