AzTrials
AzTrials

Pregnancy ComplicationsGROSSAUTOP-2NCT06779916

Autophagy/Apoptosis Balance in Placental Vascular Pathologies

An observational study of Pregnancy Complications and Pre-Eclampsia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Blood test and Urine test
How many people
50 participants
Where
1 siteFrance
Study dates
2 May 2025to 1 May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

France1 site, 1 recruiting

  • Nimes University Hospital

    Nîmes

    sylvie bouvier, 0466686868, sylvie.bouvier@chu-nimes.fr

    Recruiting

Other trials in France

About this study

Official title: Study of the 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.

Read the 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.

Being tested
Blood test, Urine test
Keywords
trophoblasts, autophagy, apoptosis, placenta, pregnancy
Medical subject headings
Pregnancy Complications, Pre-Eclampsia, Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood testDiagnostic 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 testDiagnostic test

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

Study groups in NCT06779916
Study groupRoleWhat they receive
Pregnant women developing placental vascular complicationsPregnant adult women developing placental vascular complications such as preeclampsia and/or intrauterine growth retardation, hospitalized and delivering at Nimes University Hospital.
Receives: Diagnostic Test: Blood test; Diagnostic Test: Urine test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

  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

    Measured: Month 1

  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

    Measured: Month 2

  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

    Measured: Month 3

  5. 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

    Measured: Month 4

  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

    Measured: At delivery

Secondary outcomes (172)

  1. Apoptosis activity

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

    Measured: Baseline

  2. A. Apoptosis activity

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

    Measured: Month 1

  3. A. Apoptosis activity

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

    Measured: Month 2

  4. A. Apoptosis activity

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

    Measured: Month 3

  5. A. Apoptosis activity

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

    Measured: Month 4

  6. A. Apoptosis activity

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

    Measured: At delivery

  7. B. Autophagy/apoptosis balance

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

    Measured: Baseline

  8. B. Autophagy/apoptosis balance

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

    Measured: Month 1

  9. B. Autophagy/apoptosis balance

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

    Measured: Month 2

  10. B. Autophagy/apoptosis balance

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

    Measured: Month 3

  11. B. Autophagy/apoptosis balance

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

    Measured: Month 4

  12. B. Autophagy/apoptosis balance

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

    Measured: At delivery

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

    LC3 protein will be measured as a %

    Measured: Baseline

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

    LC3 protein will be measured as a %

    Measured: Month 1

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

    LC3 protein will be measured as a %

    Measured: Month 2

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

    LC3 protein will be measured as a %

    Measured: Month 3

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

    LC3 protein will be measured as a %

    Measured: Month 4

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

    LC3 protein will be measured as a %

    Measured: At delivery

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

    Cells expressing annexin-V will be measured as a %

    Measured: Baseline

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

    Cells expressing annexin-V will be measured as a %

    Measured: Month 1

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

    Cells expressing annexin-V will be measured as a %

    Measured: Month 2

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

    Cells expressing annexin-V will be measured as a %

    Measured: Month 3

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

    Cells expressing annexin-V will be measured as a %

    Measured: Month 4

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

    Cells expressing annexin-V will be measured as a %

    Measured: At delivery

  25. D. Concentration of circulating Placental Growth Factor

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

    Measured: Baseline

  26. D. Concentration of circulating Placental Growth Factor

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

    Measured: Month 1

  27. D. Concentration of circulating Placental Growth Factor

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

    Measured: Month 2

  28. D. Concentration of circulating Placental Growth Factor

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

    Measured: Month 3

  29. D. Concentration of circulating Placental Growth Factor

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

    Measured: Month 4

  30. D. Concentration of circulating Placental Growth Factor

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

    Measured: At delivery

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

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

    Measured: Baseline

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

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

    Measured: Month 1

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

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

    Measured: Month 2

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

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

    Measured: Month 3

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

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

    Measured: Month 4

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

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

    Measured: At delivery

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

    Proteinuria will be measured in mg/L

    Measured: Baseline

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

    Proteinuria will be measured in mg/L

    Measured: Month 1

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

    Proteinuria will be measured in mg/L

    Measured: Month 2

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

    Proteinuria will be measured in mg/L

    Measured: Month 3

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

    Proteinuria will be measured in mg/L

    Measured: Month 4

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

    Proteinuria will be measured in mg/L

    Measured: At delivery

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

    Creatinuria will be measured in mmol/L

    Measured: Baseline

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

    Creatinuria will be measured in mmol/L

    Measured: Month 1

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

    Creatinuria will be measured in mmol/L

    Measured: Month 2

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

    Creatinuria will be measured in mmol/L

    Measured: Month 3

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

    Creatinuria will be measured in mmol/L

    Measured: Month 4

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

    Creatinuria will be measured in mmol/L

    Measured: At delivery

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

    C-reactive protein will be measured in mg/L

    Measured: Baseline

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

    C-reactive protein will be measured in mg/L

    Measured: Month 1

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

    C-reactive protein will be measured in mg/L

    Measured: Month 2

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

    C-reactive protein will be measured in mg/L

    Measured: Month 3

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

    C-reactive protein will be measured in mg/L

    Measured: Month 4

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

    C-reactive protein will be measured in mg/L

    Measured: At delivery

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

    Fibrinogen will be measured in g/L

    Measured: Baseline

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

    Fibrinogen will be measured in g/L

    Measured: Month 1

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

    Fibrinogen will be measured in g/L

    Measured: Month 2

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

    Fibrinogen will be measured in g/L

    Measured: Month 3

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

    Fibrinogen will be measured in g/L

    Measured: Month 4

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

    Fibrinogen will be measured in g/L

    Measured: At delivery

  61. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: Baseline

  62. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: Month 1

  63. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: Month 2

  64. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: Month 3

  65. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: Month 4

  66. E. Coagulation parameters : activated partial thromboplastin time

    Activated partial thromboplastin time will be measured in seconds

    Measured: At delivery

  67. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: Baseline

  68. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: Month 1

  69. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: Month 2

  70. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: Month 3

  71. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: Month 4

  72. E. Coagulation parameters : Prothrombin time

    Prothrombin time will be measured in seconds

    Measured: At delivery

  73. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: Baseline

  74. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: Month 1

  75. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: Month 2

  76. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: Month 3

  77. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: Month 4

  78. E. Coagulation parameters : Fibrinogen

    Fibrinogen will be measured in g/L

    Measured: At delivery

  79. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: Baseline

  80. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: Month 1

  81. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: Month 2

  82. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: Month 3

  83. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: Month 4

  84. E. Coagulation parameters : D-dimers

    D-dimers will be measured in ng/mL

    Measured: At delivery

  85. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: Baseline

  86. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: Month 1

  87. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: Month 2

  88. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: Month 3

  89. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: Month 4

  90. E. Coagulation parameters : Fibrin monomers

    Fibrin monomers will be measured in mg/mL

    Measured: At delivery

  91. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: Baseline

  92. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: Month 1

  93. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: Month 2

  94. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: Month 3

  95. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: Month 4

  96. E. Coagulation parameters : Thrombin generation time

    Thrombin generation time will be measured in seconds

    Measured: At delivery

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

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

    Measured: Baseline

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

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

    Measured: Month 1

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

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

    Measured: Month 2

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

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

    Measured: Month 3

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

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

    Measured: Month 4

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

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

    Measured: At delivery

  103. Complete Blood Count : Red blood cells

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

    Measured: Baseline

  104. Complete Blood Count : Red blood cells

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

    Measured: Month 1

  105. Complete Blood Count : Red blood cells

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

    Measured: Month 2

  106. Complete Blood Count : Red blood cells

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

    Measured: Month 3

  107. Complete Blood Count : Red blood cells

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

    Measured: Month 4

  108. Complete Blood Count : Red blood cells

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

    Measured: At delivery

  109. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: Baseline

  110. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: Month 1

  111. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: Month 2

  112. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: Month 3

  113. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: Month 4

  114. Complete Blood Count : Hemoglobin

    Hemoglobin will be measured in g/L

    Measured: At delivery

  115. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: Baseline

  116. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: Month 1

  117. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: Month 2

  118. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: Month 3

  119. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: Month 4

  120. Complete Blood Count : Platelets

    Platelets will be measured in %

    Measured: At delivery

  121. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: Baseline

  122. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: Month 1

  123. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: Month 2

  124. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: Month 3

  125. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: Month 4

  126. Complete Blood Count : Hematocrit

    Hematocrit will be measured in %

    Measured: At delivery

  127. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: Baseline

  128. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: Month 1

  129. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: Month 2

  130. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: Month 3

  131. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: Month 4

  132. Complete Blood Count : Mean Corpuscular Volume

    Mean Corpuscular Volume will be measured in f/L

    Measured: At delivery

  133. Complete Blood Count : Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin will be measured in pg

    Measured: Baseline

  134. Complete Blood Count : Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin will be measured in pg

    Measured: Month 1

  135. Complete Blood Count : Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin will be measured in pg

    Measured: Month 2

  136. Complete Blood Count : Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin will be measured in pg

    Measured: Month 3

  137. Complete Blood Count : Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin will be measured in pg

    Measured: Month 4

  138. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

    Measured: Baseline

  139. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

    Measured: Month 1

  140. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

    Measured: Month 2

  141. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

    Measured: Month 3

  142. Complete Blood Count : Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration will be measured in g/L

    Measured: At delivery

  143. Ferritin

    Ferritin will be measured in ng/mL

    Measured: Baseline

  144. Ferritin

    Ferritin will be measured in ng/mL

    Measured: Month 1

  145. Ferritin

    Ferritin will be measured in ng/mL

    Measured: Month 2

  146. Ferritin

    Ferritin will be measured in ng/mL

    Measured: Month 3

  147. Ferritin

    Ferritin will be measured in ng/mL

    Measured: Month 4

  148. Ferritin

    Ferritin will be measured in ng/mL

    Measured: At delivery

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

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

    Measured: Baseline

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

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

    Measured: Month 1

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

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

    Measured: Month 2

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

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

    Measured: Month 3

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

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

    Measured: Month 4

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

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

    Measured: At delivery

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

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

    Measured: Baseline

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

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

    Measured: Month 1

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

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

    Measured: Month 2

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

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

    Measured: Month 3

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

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

    Measured: Month 4

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

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

    Measured: At delivery

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

    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).

    Measured: Baseline

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

    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).

    Measured: Month 1

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

    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).

    Measured: Month 2

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

    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).

    Measured: Month 3

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

    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).

    Measured: Month 4

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

    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).

    Measured: At delivery

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

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

    Measured: Baseline

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

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

    Measured: Month 1

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

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

    Measured: Month 2

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

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

    Measured: Month 3

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

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

    Measured: Month 4

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

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

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start2 May 2025
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779916
Sponsor's protocol ID
NIMAO/2024-1/SB01
Acronym
GROSSAUTOP-2
Status last verified
Apr 2026
First submitted
6 Jan 2025
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Complications and Pre-Eclampsia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sylvie BOUVIER, Dr. (+334.66.68.32.11, sylvie.bouvier@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of cells expressing LC3 (microtubule-associated protein light chain 3) protein (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06779916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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