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NCT Number: NCT06779916

Autophagy/Apoptosis Balance in Placental Vascular Pathologies

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nimes University Hospital

Nîmes, France

Location status: Recruiting

Location contact

sylvie bouvier

CONTACT

[email protected]

0466686868

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Urine test

Diagnostic Test

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

Primary outcomes

  1. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: Baseline

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

  2. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: Month 1

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

  3. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: Month 2

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

  4. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: Month 3

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

  5. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: Month 4

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

  6. Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

    Time frame: At delivery

    Level of autophagy in trophoblastic test cells quantified by the percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein

Secondary outcomes

  1. Apoptosis activity

    Time frame: Baseline

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  2. A. Apoptosis activity

    Time frame: Month 1

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  3. A. Apoptosis activity

    Time frame: Month 2

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  4. A. Apoptosis activity

    Time frame: Month 3

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  5. A. Apoptosis activity

    Time frame: Month 4

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  6. A. Apoptosis activity

    Time frame: At delivery

    Percentage of cells expressing annexin-V in pregnant women developing placental vascular pathology

  7. B. Autophagy/apoptosis balance

    Time frame: Baseline

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  8. B. Autophagy/apoptosis balance

    Time frame: Month 1

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  9. B. Autophagy/apoptosis balance

    Time frame: Month 2

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  10. B. Autophagy/apoptosis balance

    Time frame: Month 3

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  11. B. Autophagy/apoptosis balance

    Time frame: Month 4

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  12. B. Autophagy/apoptosis balance

    Time frame: At delivery

    Ratio between percentage of cells expressing LC3 protein and percentage of cells expressing annexin-V

  13. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: Baseline

    LC3 protein will be measured as a %

  14. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: Month 1

    LC3 protein will be measured as a %

  15. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: Month 2

    LC3 protein will be measured as a %

  16. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: Month 3

    LC3 protein will be measured as a %

  17. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: Month 4

    LC3 protein will be measured as a %

  18. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: LC3 protein

    Time frame: At delivery

    LC3 protein will be measured as a %

  19. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: Baseline

    Cells expressing annexin-V will be measured as a %

  20. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: Month 1

    Cells expressing annexin-V will be measured as a %

  21. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: Month 2

    Cells expressing annexin-V will be measured as a %

  22. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: Month 3

    Cells expressing annexin-V will be measured as a %

  23. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: Month 4

    Cells expressing annexin-V will be measured as a %

  24. C.Kinetics of different biological activities (autophagy, apoptosis, autophagy/apoptosis balance) during pregnancy follow-up: cells expressing annexin-V

    Time frame: At delivery

    Cells expressing annexin-V will be measured as a %

  25. D. Concentration of circulating Placental Growth Factor

    Time frame: Baseline

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  26. D. Concentration of circulating Placental Growth Factor

    Time frame: Month 1

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  27. D. Concentration of circulating Placental Growth Factor

    Time frame: Month 2

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  28. D. Concentration of circulating Placental Growth Factor

    Time frame: Month 3

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  29. D. Concentration of circulating Placental Growth Factor

    Time frame: Month 4

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  30. D. Concentration of circulating Placental Growth Factor

    Time frame: At delivery

    Circulating Placental Growth Factor measured on blood samples in pg/mL

  31. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: Baseline

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  32. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: Month 1

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  33. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: Month 2

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  34. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: Month 3

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  35. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: Month 4

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  36. D. Concentration of circulating soluble fms-like tyrosine kinase receptor-1

    Time frame: At delivery

    Circulating soluble fms-like tyrosine kinase receptor-1 measured on blood samples in pg/mL

  37. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: Baseline

    Proteinuria will be measured in mg/L

  38. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: Month 1

    Proteinuria will be measured in mg/L

  39. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: Month 2

    Proteinuria will be measured in mg/L

  40. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: Month 3

    Proteinuria will be measured in mg/L

  41. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: Month 4

    Proteinuria will be measured in mg/L

  42. E. Correlation between autophagy/apoptosis balance and markers of renal function: proteinuria

    Time frame: At delivery

    Proteinuria will be measured in mg/L

  43. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: Baseline

    Creatinuria will be measured in mmol/L

  44. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: Month 1

    Creatinuria will be measured in mmol/L

  45. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: Month 2

    Creatinuria will be measured in mmol/L

  46. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: Month 3

    Creatinuria will be measured in mmol/L

  47. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: Month 4

    Creatinuria will be measured in mmol/L

  48. E. Correlation between autophagy/apoptosis balance and markers of renal function: creatinuria

    Time frame: At delivery

    Creatinuria will be measured in mmol/L

  49. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: Baseline

    C-reactive protein will be measured in mg/L

  50. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: Month 1

    C-reactive protein will be measured in mg/L

  51. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: Month 2

    C-reactive protein will be measured in mg/L

  52. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: Month 3

    C-reactive protein will be measured in mg/L

  53. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: Month 4

    C-reactive protein will be measured in mg/L

  54. E. Correlation between autophagy/apoptosis balance and markers of renal function: C-reactive protein

    Time frame: At delivery

    C-reactive protein will be measured in mg/L

  55. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: Baseline

    Fibrinogen will be measured in g/L

  56. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: Month 1

    Fibrinogen will be measured in g/L

  57. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: Month 2

    Fibrinogen will be measured in g/L

  58. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: Month 3

    Fibrinogen will be measured in g/L

  59. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: Month 4

    Fibrinogen will be measured in g/L

  60. E. Correlation between autophagy/apoptosis balance and markers of renal function: Fibrinogen

    Time frame: At delivery

    Fibrinogen will be measured in g/L

  61. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: Baseline

    Activated partial thromboplastin time will be measured in seconds

  62. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: Month 1

    Activated partial thromboplastin time will be measured in seconds

  63. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: Month 2

    Activated partial thromboplastin time will be measured in seconds

  64. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: Month 3

    Activated partial thromboplastin time will be measured in seconds

  65. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: Month 4

    Activated partial thromboplastin time will be measured in seconds

  66. E. Coagulation parameters : activated partial thromboplastin time

    Time frame: At delivery

    Activated partial thromboplastin time will be measured in seconds

  67. E. Coagulation parameters : Prothrombin time

    Time frame: Baseline

    Prothrombin time will be measured in seconds

  68. E. Coagulation parameters : Prothrombin time

    Time frame: Month 1

    Prothrombin time will be measured in seconds

  69. E. Coagulation parameters : Prothrombin time

    Time frame: Month 2

    Prothrombin time will be measured in seconds

  70. E. Coagulation parameters : Prothrombin time

    Time frame: Month 3

    Prothrombin time will be measured in seconds

  71. E. Coagulation parameters : Prothrombin time

    Time frame: Month 4

    Prothrombin time will be measured in seconds

  72. E. Coagulation parameters : Prothrombin time

    Time frame: At delivery

    Prothrombin time will be measured in seconds

  73. E. Coagulation parameters : Fibrinogen

    Time frame: Baseline

    Fibrinogen will be measured in g/L

  74. E. Coagulation parameters : Fibrinogen

    Time frame: Month 1

    Fibrinogen will be measured in g/L

  75. E. Coagulation parameters : Fibrinogen

    Time frame: Month 2

    Fibrinogen will be measured in g/L

  76. E. Coagulation parameters : Fibrinogen

    Time frame: Month 3

    Fibrinogen will be measured in g/L

  77. E. Coagulation parameters : Fibrinogen

    Time frame: Month 4

    Fibrinogen will be measured in g/L

  78. E. Coagulation parameters : Fibrinogen

    Time frame: At delivery

    Fibrinogen will be measured in g/L

  79. E. Coagulation parameters : D-dimers

    Time frame: Baseline

    D-dimers will be measured in ng/mL

  80. E. Coagulation parameters : D-dimers

    Time frame: Month 1

    D-dimers will be measured in ng/mL

  81. E. Coagulation parameters : D-dimers

    Time frame: Month 2

    D-dimers will be measured in ng/mL

  82. E. Coagulation parameters : D-dimers

    Time frame: Month 3

    D-dimers will be measured in ng/mL

  83. E. Coagulation parameters : D-dimers

    Time frame: Month 4

    D-dimers will be measured in ng/mL

  84. E. Coagulation parameters : D-dimers

    Time frame: At delivery

    D-dimers will be measured in ng/mL

  85. E. Coagulation parameters : Fibrin monomers

    Time frame: Baseline

    Fibrin monomers will be measured in mg/mL

  86. E. Coagulation parameters : Fibrin monomers

    Time frame: Month 1

    Fibrin monomers will be measured in mg/mL

  87. E. Coagulation parameters : Fibrin monomers

    Time frame: Month 2

    Fibrin monomers will be measured in mg/mL

  88. E. Coagulation parameters : Fibrin monomers

    Time frame: Month 3

    Fibrin monomers will be measured in mg/mL

  89. E. Coagulation parameters : Fibrin monomers

    Time frame: Month 4

    Fibrin monomers will be measured in mg/mL

  90. E. Coagulation parameters : Fibrin monomers

    Time frame: At delivery

    Fibrin monomers will be measured in mg/mL

  91. E. Coagulation parameters : Thrombin generation time

    Time frame: Baseline

    Thrombin generation time will be measured in seconds

  92. E. Coagulation parameters : Thrombin generation time

    Time frame: Month 1

    Thrombin generation time will be measured in seconds

  93. E. Coagulation parameters : Thrombin generation time

    Time frame: Month 2

    Thrombin generation time will be measured in seconds

  94. E. Coagulation parameters : Thrombin generation time

    Time frame: Month 3

    Thrombin generation time will be measured in seconds

  95. E. Coagulation parameters : Thrombin generation time

    Time frame: Month 4

    Thrombin generation time will be measured in seconds

  96. E. Coagulation parameters : Thrombin generation time

    Time frame: At delivery

    Thrombin generation time will be measured in seconds

  97. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: Baseline

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  98. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: Month 1

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  99. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: Month 2

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  100. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: Month 3

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  101. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: Month 4

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  102. Complete Blood Count : White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils

    Time frame: At delivery

    White blood cells, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils will be measured in 10^9/L

  103. Complete Blood Count : Red blood cells

    Time frame: Baseline

    Red blood cells will be measured in 10^12/L

  104. Complete Blood Count : Red blood cells

    Time frame: Month 1

    Red blood cells will be measured in 10^12/L

  105. Complete Blood Count : Red blood cells

    Time frame: Month 2

    Red blood cells will be measured in 10^12/L

  106. Complete Blood Count : Red blood cells

    Time frame: Month 3

    Red blood cells will be measured in 10^12/L

  107. Complete Blood Count : Red blood cells

    Time frame: Month 4

    Red blood cells will be measured in 10^12/L

  108. Complete Blood Count : Red blood cells

    Time frame: At delivery

    Red blood cells will be measured in 10^12/L

  109. Complete Blood Count : Hemoglobin

    Time frame: Baseline

    Hemoglobin will be measured in g/L

  110. Complete Blood Count : Hemoglobin

    Time frame: Month 1

    Hemoglobin will be measured in g/L

  111. Complete Blood Count : Hemoglobin

    Time frame: Month 2

    Hemoglobin will be measured in g/L

  112. Complete Blood Count : Hemoglobin

    Time frame: Month 3

    Hemoglobin will be measured in g/L

  113. Complete Blood Count : Hemoglobin

    Time frame: Month 4

    Hemoglobin will be measured in g/L

  114. Complete Blood Count : Hemoglobin

    Time frame: At delivery

    Hemoglobin will be measured in g/L

  115. Complete Blood Count : Platelets

    Time frame: Baseline

    Platelets will be measured in %

  116. Complete Blood Count : Platelets

    Time frame: Month 1

    Platelets will be measured in %

  117. Complete Blood Count : Platelets

    Time frame: Month 2

    Platelets will be measured in %

  118. Complete Blood Count : Platelets

    Time frame: Month 3

    Platelets will be measured in %

  119. Complete Blood Count : Platelets

    Time frame: Month 4

    Platelets will be measured in %

  120. Complete Blood Count : Platelets

    Time frame: At delivery

    Platelets will be measured in %

  121. Complete Blood Count : Hematocrit

    Time frame: Baseline

    Hematocrit will be measured in %

  122. Complete Blood Count : Hematocrit

    Time frame: Month 1

    Hematocrit will be measured in %

  123. Complete Blood Count : Hematocrit

    Time frame: Month 2

    Hematocrit will be measured in %

  124. Complete Blood Count : Hematocrit

    Time frame: Month 3

    Hematocrit will be measured in %

  125. Complete Blood Count : Hematocrit

    Time frame: Month 4

    Hematocrit will be measured in %

  126. Complete Blood Count : Hematocrit

    Time frame: At delivery

    Hematocrit will be measured in %

  127. Complete Blood Count : Mean Corpuscular Volume

    Time frame: Baseline

    Mean Corpuscular Volume will be measured in f/L

  128. Complete Blood Count : Mean Corpuscular Volume

    Time frame: Month 1

    Mean Corpuscular Volume will be measured in f/L

  129. Complete Blood Count : Mean Corpuscular Volume

    Time frame: Month 2

    Mean Corpuscular Volume will be measured in f/L

  130. Complete Blood Count : Mean Corpuscular Volume

    Time frame: Month 3

    Mean Corpuscular Volume will be measured in f/L

  131. Complete Blood Count : Mean Corpuscular Volume

    Time frame: Month 4

    Mean Corpuscular Volume will be measured in f/L

  132. Complete Blood Count : Mean Corpuscular Volume

    Time frame: At delivery

    Mean Corpuscular Volume will be measured in f/L

  133. Complete Blood Count : Mean Corpuscular Hemoglobin

    Time frame: Baseline

    Mean Corpuscular Hemoglobin will be measured in pg

  134. Complete Blood Count : Mean Corpuscular Hemoglobin

    Time frame: Month 1

    Mean Corpuscular Hemoglobin will be measured in pg

  135. Complete Blood Count : Mean Corpuscular Hemoglobin

    Time frame: Month 2

    Mean Corpuscular Hemoglobin will be measured in pg

  136. Complete Blood Count : Mean Corpuscular Hemoglobin

    Time frame: Month 3

    Mean Corpuscular Hemoglobin will be measured in pg

  137. Complete Blood Count : Mean Corpuscular Hemoglobin

    Time frame: Month 4

    Mean Corpuscular Hemoglobin will be measured in pg

  138. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Time frame: Baseline

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  139. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Time frame: Month 1

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  140. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Time frame: Month 2

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  141. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Time frame: Month 3

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  142. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Time frame: At delivery

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

  143. Ferritin

    Time frame: Baseline

    Ferritin will be measured in ng/mL

  144. Ferritin

    Time frame: Month 1

    Ferritin will be measured in ng/mL

  145. Ferritin

    Time frame: Month 2

    Ferritin will be measured in ng/mL

  146. Ferritin

    Time frame: Month 3

    Ferritin will be measured in ng/mL

  147. Ferritin

    Time frame: Month 4

    Ferritin will be measured in ng/mL

  148. Ferritin

    Time frame: At delivery

    Ferritin will be measured in ng/mL

  149. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: Baseline

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  150. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: Month 1

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  151. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: Month 2

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  152. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: Month 3

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  153. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: Month 4

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  154. F. Association between autophagy/apoptosis balance and the presence of constitutive thrombophilia

    Time frame: At delivery

    Constitutive thrombophilia: presence of prothrombin or factor V Leiden gene mutation, protein S, C, antithrombin deficiency will be sought: YES/NO

  155. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: Baseline

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein 1 and/or anti-cardiolipid) will be sought: YES/NO

  156. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: Month 1

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein1 and/or anti-cardiolipid) will be sought: YES/NO

  157. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: Month 2

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein1 and/or anti-cardiolipid) will be sought: YES/NO

  158. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: Month 3

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein 1 and/or anti-cardiolipid) will be sought: YES/NO

  159. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: Month 4

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein 1 and/or anti-cardiolipid) will be sought: YES/NO

  160. F. Association between autophagy/apoptosis balance and the presence of acquired thrombophilia

    Time frame: At delivery

    Acquired thrombophilia: presence of anti-phospholipid antibodies (lupus anticoagulant and/or anti-b2-glycoprotein 1 and/or anti-cardiolipid) will be sought: YES/NO

  161. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: Baseline

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  162. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: Month 1

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  163. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: Month 2

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  164. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: Month 3

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  165. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: Month 4

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  166. Comparison of results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance

    Time frame: At delivery

    The results on trophoblastic cell autophagy induction potential, apoptosis and autophagy/apoptosis balance) will be compared with data obtained from the first GrossAuTop-1 study (normal pregnancy).

  167. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: Baseline

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

  168. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: Month 1

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

  169. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: Month 2

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

  170. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: Month 3

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

  171. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: Month 4

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

  172. H.Association between autophagy/apoptosis balance and HbF levels in maternal blood during pregnancy.

    Time frame: At delivery

    Determination of fetal hemoglobin (HbF) in maternal blood, measured in %

Other outcomes

  1. I. Constitution of a Biobank

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+334 66 68 42 36

Sylvie BOUVIER, Dr.

CONTACT

[email protected]

+334.66.68.32.11

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Study of the Autophagy/Apoptosis Balance in Placental Vascular Pathologies

Acronym: GROSSAUTOP-2

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 17, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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