Autophagy/Apoptosis Balance in Placental Vascular Pathologies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood test
Diagnostic test16 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
Diagnostic testUrine samples will be taken at the inclusion visit and at each follow-up visit.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Pregnant women developing placental vascular complications2 interventions
Trial outcomes
Primary outcomes
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
Time frame
Baseline2
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
Time frame
Month 13
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
Time frame
Month 24
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
Time frame
Month 3Secondary outcomes
1
Apoptosis activity
Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology
Time frame
Baseline2
A. Apoptosis activity
Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology
Time frame
Month 13
A. Apoptosis activity
Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology
Time frame
Month 24
A. Apoptosis activity
Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology
Time frame
Month 3Other outcomes
1
I. Constitution of a Biobank
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov