NCT06779916|Recruiting
Autophagy/Apoptosis Balance in Placental Vascular Pathologies
GROSSAUTOP-2
Study of the Autophagy/Apoptosis Balance in Placental Vascular Pathologies
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GROSSAUTOP-2
Study of the Autophagy/Apoptosis Balance in Placental Vascular Pathologies
Sponsor study identifier
observational
50
1 country
1
Study Start
May 2, 2025
Actual (reported)Primary Completion
May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2025
Actual (reported)January 17, 2025
Actual (reported)May 2, 2025
Actual (reported)May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Baseline
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Month 1
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Pregnant adult women developing placental vascular complications such as preeclampsia and/or intrauterine growth retardation, hospitalized and delivering at Nimes University Hospital.
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 samples will be taken at the inclusion visit and at each follow-up visit.
An initial analysis of the data will make it possible to describe the population. Quantitative variables will be expressed as mean and standard deviation, or median and quartiles. Qualitative variables will be expressed in headcount and percentage.
Nimes University Hospital
Nîmes, France
A biobank (plasmabank, serum bank, mononuclear cells) will be set up for ancillary studies on other markers of placental vascular pathologies and venous thromboembolic disease.
Marie PORTES, Dr.
Centre Hospitalier Universitaire de Nīmes
Mathieu FORTIER, Dr.
Centre Hospitalier Universitaire de Nīmes
Jean-Christophe GRIS, Pr.
Centre Hospitalier Universitaire de Nīmes
Eve MOUSTY, Dr.
Centre Hospitalier Universitaire de Nīmes
First Submitted
January 6, 2025
First Posted
January 17, 2025
Study Start
May 2, 2025
Actual (reported)Primary Completion
May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study of Placental Vascularization Using Contrast Ultrasound
Month 2
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Month 3
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Month 4
Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
At delivery
Apoptosis activity
Baseline
A. Apoptosis activity
Month 1
A. Apoptosis activity
Month 2
A. Apoptosis activity
Month 3
A. Apoptosis activity
Month 4
I. Constitution of a Biobank
Baseline
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Vincent LETOUZEY, Dr.
Centre Hospitalier Universitaire de Nīmes
Stéphanie HUBERLANT, Dr.
Centre Hospitalier Universitaire de Nīmes
Chloé BOURGUIGNON, Dr.
Centre Hospitalier Universitaire de Nīmes
Study Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
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