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Recruiting Observational

Autophagy/Apoptosis Balance in Placental Vascular Pathologies

NCT06779916 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-05-02
Last updated
2026-05-06

Condition(s) studied

Pregnancy ComplicationsPre-EclampsiaGrowth Retardation, Intrauterine

Investigational drug(s) / intervention(s)

Blood testUrine test

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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — Baseline
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — Month 1
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — Month 2
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — Month 3
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — Month 4
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein — At delivery
    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

Trial sites (1)

FacilityCityRegionStatus
Nimes University Hospital Nîmes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779916 on ClinicalTrials.gov ↗ ← All trials in France