Autophagy/Apoptosis Balance in Placental Vascular Pathologies

NCT06779916 | Recruiting

• 1 other identifier: NIMAO/2024-1/SB01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications; Pre-Eclampsia; Growth Retardation, Intrauterine

Keywords

trophoblasts; autophagy; apoptosis; placenta; pregnancy

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (172)

• Apoptosis activity

  Baseline

• A. Apoptosis activity

  Month 1

• A. Apoptosis activity

  Month 2

• A. Apoptosis activity

  Month 3

• A. Apoptosis activity

  Month 4

Other Outcomes (1)

• I. Constitution of a Biobank

  Baseline

Study Arms (1)

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.

Diagnostic Test: Blood test; Diagnostic Test: Urine test

Interventions

Blood test 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.

Pregnant women developing placental vascular complications

Urine test DIAGNOSTIC_TEST

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

Pregnant women developing placental vascular complications

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Multiple pregnancy.
• Presence of hypertension and/or proteinuria prior to pregnancy.
• Participant in an interventional drug study.
• Persons under court protection, guardianship or curatorship.
• Persons unable to give consent.
• Persons for whom it is impossible to give informed information.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Fetal Growth Retardation

Interventions

Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Marie PORTES, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Mathieu FORTIER, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Jean-Christophe GRIS, Pr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Eve MOUSTY, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Vincent LETOUZEY, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Stéphanie HUBERLANT, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Chloé BOURGUIGNON, Dr.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie BOUVIER, Dr.

CONTACT

+334.66.68.32.11; sylvie.bouvier@chu-nimes.fr

Anissa MEGZARI

CONTACT

+334 66 68 42 36; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)