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Recruiting NCT06779916

Autophagy/Apoptosis Balance in Placental Vascular Pathologies

— Observational Pregnancy Complications Pre-Eclampsia Growth Retardation, Intrauterine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood test, Urine test.
Who it may be relevant to
Registry conditions: Pregnancy Complications, Pre-Eclampsia, Growth Retardation, Intrauterine. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study of the Autophagy/Apoptosis Balance in Placental Vascular Pathologies

Overview

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

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.

Interventions

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

Primary outcome measures

  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: Baseline]
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: Month 1]
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: Month 2]
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: Month 3]
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: Month 4]
  • Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein [Time frame: At delivery]
Secondary outcome measures (12)
  • Apoptosis activity [Time frame: Baseline]
  • A. Apoptosis activity [Time frame: Month 1]
  • A. Apoptosis activity [Time frame: Month 2]
  • A. Apoptosis activity [Time frame: Month 3]
  • A. Apoptosis activity [Time frame: Month 4]
  • A. Apoptosis activity [Time frame: At delivery]
  • B. Autophagy/apoptosis balance [Time frame: Baseline]
  • B. Autophagy/apoptosis balance [Time frame: Month 1]
  • B. Autophagy/apoptosis balance [Time frame: Month 2]
  • B. Autophagy/apoptosis balance [Time frame: Month 3]
  • B. Autophagy/apoptosis balance [Time frame: Month 4]
  • B. Autophagy/apoptosis balance [Time frame: At delivery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Nimes University Hospital — Nîmes

Identifiers

NCT: NCT06779916 · NIMAO/2024-1/SB01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗