Skip to main content
OpenTrials
Completed

NCT Number: NCT04443660

Autophagy/Apoptosis Balance During Pregnancy

The object of this study is to assess the intra- and inter-individual variability of apoptosis and autophagy activities in women during pregnancy: 1 / in women with a normal pregnancy and 2 / in pregnant women particularly at risk of complications.

The study investigators hypothesize that there would be an intra-trophoblastic dialogue between the mechanisms of autophagy and apoptosis, the promotion of one partially inhibiting the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an anti-apoptosis defense phenomenon, the exhaustion of which would lead to cellular apoptosis and to pathogenic consequences when it devastates the syncytiotrophoblast.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients followed at the CHU Nimes prior to 33 weeks gestation who give birth at the hospital
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion criteria

  • The subject is participating in a category 1 interventional study associated with a medication, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Multiple pregnancy

Treatment and study plan

Blood Test

Other

Blood samples taken to test levels of autophagy and apoptosis

Primary outcomes

  1. Potential autophagy induction activity in all groups

    Time frame: Day 0

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  2. Potential autophagy induction activity in all groups

    Time frame: Month 1

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  3. Potential autophagy induction activity in all groups

    Time frame: Month 2

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  4. Potential autophagy induction activity in all groups

    Time frame: Month 3

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  5. Potential autophagy induction activity in all groups

    Time frame: Month 4

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  6. Potential autophagy induction activity in all groups

    Time frame: Month 5

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  7. Potential autophagy induction activity in all groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

Secondary outcomes

  1. Type of autophagy inhibition per patient in all groups

    Time frame: Day 0

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  2. Type of autophagy inhibition per patient in all groups

    Time frame: Month 1

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  3. Type of autophagy inhibition per patient in all groups

    Time frame: Month 2

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  4. Type of autophagy inhibition per patient in all groups

    Time frame: Month 3

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  5. Type of autophagy inhibition per patient in all groups

    Time frame: Month 4

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  6. Type of autophagy inhibition per patient in all groups

    Time frame: Month 5

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  7. Type of autophagy inhibition per patient in all groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  8. Potential apoptosis induction activity in all groups

    Time frame: Day 0

    % cells positive for Annexin V

  9. Potential apoptosis induction activity in all groups

    Time frame: Month 1

    % cells positive for Annexin V

  10. Potential apoptosis induction activity in all groups

    Time frame: Month 2

    % cells positive for Annexin V

  11. Potential apoptosis induction activity in all groups

    Time frame: Month 3

    % cells positive for Annexin V

  12. Potential apoptosis induction activity in all groups

    Time frame: Month 4

    % cells positive for Annexin V

  13. Potential apoptosis induction activity in all groups

    Time frame: Month 5

    % cells positive for Annexin V

  14. Potential apoptosis induction activity in all groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    % cells positive for Annexin V

  15. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Day 0

  16. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Month 1

  17. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Month 2

  18. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Month 3

  19. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Month 4

  20. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Month 5

  21. Inter- and intra-individual apoptosis/autophagy ratio in all groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

  22. Autophagy kinetics between groups

    Time frame: Day 0

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  23. Autophagy kinetics between groups

    Time frame: Month 1

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  24. Autophagy kinetics between groups

    Time frame: Month 2

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  25. Autophagy kinetics between groups

    Time frame: Month 3

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  26. Autophagy kinetics between groups

    Time frame: Month 4

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  27. Autophagy kinetics between groups

    Time frame: Month 5

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  28. Autophagy kinetics between groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  29. Apoptosis kinetics between groups

    Time frame: Day 0

    measured by % cells positive for Annexin V

  30. Apoptosis kinetics between groups

    Time frame: Month 1

    measured by % cells positive for Annexin V

  31. Apoptosis kinetics between groups

    Time frame: Month 2

    measured by % cells positive for Annexin V

  32. Apoptosis kinetics between groups

    Time frame: Month 3

    measured by % cells positive for Annexin V

  33. Apoptosis kinetics between groups

    Time frame: Month 4

    measured by % cells positive for Annexin V

  34. Apoptosis kinetics between groups

    Time frame: Month 5

    measured by % cells positive for Annexin V

  35. Apoptosis kinetics between groups

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    measured by % cells positive for Annexin V

  36. Placental Growth Factor in each group

    Time frame: Day 0

    pg/ml measured by ELISA

  37. Placental Growth Factor in each group

    Time frame: Month 1

    pg/ml measured by ELISA

  38. Placental Growth Factor in each group

    Time frame: Month 2

    pg/ml measured by ELISA

  39. Placental Growth Factor in each group

    Time frame: Month 3

    pg/ml measured by ELISA

  40. Placental Growth Factor in each group

    Time frame: Month 4

    pg/ml measured by ELISA

  41. Placental Growth Factor in each group

    Time frame: Month 5

    pg/ml measured by ELISA

  42. Placental Growth Factor in each group

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    pg/ml measured by ELISA

  43. Soluble fms-like tyrosine kinase-1

    Time frame: Day 0

    pg/ml measured by ELISA

  44. Soluble fms-like tyrosine kinase-1

    Time frame: Month 1

    pg/ml measured by ELISA

  45. Soluble fms-like tyrosine kinase-1

    Time frame: Month 2

    pg/ml measured by ELISA

  46. Soluble fms-like tyrosine kinase-1

    Time frame: Month 3

    pg/ml measured by ELISA

  47. Soluble fms-like tyrosine kinase-1

    Time frame: Month 4

    pg/ml measured by ELISA

  48. Soluble fms-like tyrosine kinase-1

    Time frame: Month 5

    pg/ml measured by ELISA

  49. Soluble fms-like tyrosine kinase-1

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    pg/ml measured by ELISA

  50. Constitutive thrombophilia

    Time frame: Day 0

    presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency

  51. Acquired thrombophilia

    Time frame: Day 0

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  52. Acquired thrombophilia

    Time frame: Month 1

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  53. Acquired thrombophilia

    Time frame: Month 2

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  54. Acquired thrombophilia

    Time frame: Month 3

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  55. Acquired thrombophilia

    Time frame: Month 4

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  56. Acquired thrombophilia

    Time frame: Month 5

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  57. Acquired thrombophilia

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).

  58. Whole blood count

    Time frame: Day 0

  59. Whole blood count

    Time frame: Month 1

  60. Whole blood count

    Time frame: Month 2

  61. Whole blood count

    Time frame: Month 3

  62. Whole blood count

    Time frame: Month 4

  63. Whole blood count

    Time frame: Month 5

  64. Whole blood count

    Time frame: Delivery plus or minus 2 weeks (Month 6)

  65. Renal function

    Time frame: Day 0

    creatinemia, proteinuria / creatinuria ratio

  66. Renal function

    Time frame: Month 1

    creatinemia, proteinuria / creatinuria ratio

  67. Renal function

    Time frame: Month 2

    creatinemia, proteinuria / creatinuria ratio

  68. Renal function

    Time frame: Month 3

    creatinemia, proteinuria / creatinuria ratio

  69. Renal function

    Time frame: Month 4

    creatinemia, proteinuria / creatinuria ratio

  70. Renal function

    Time frame: Month 5

    creatinemia, proteinuria / creatinuria ratio

  71. Renal function

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    creatinemia, proteinuria / creatinuria ratio

  72. Fibrin levels

    Time frame: Day 0

    D dimers and fibrin monomers

  73. Fibrin levels

    Time frame: Month 1

    D dimers and fibrin monomers

  74. Fibrin levels

    Time frame: Month 2

    D dimers and fibrin monomers

  75. Fibrin levels

    Time frame: Month 3

    D dimers and fibrin monomers

  76. Fibrin levels

    Time frame: Month 4

    D dimers and fibrin monomers

  77. Fibrin levels

    Time frame: Month 5

    D dimers and fibrin monomers

  78. Fibrin levels

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    D dimers and fibrin monomers

  79. Inflammation

    Time frame: Day 0

    C-reactive protein level

  80. Inflammation

    Time frame: Month 1

    C-reactive protein level

  81. Inflammation

    Time frame: Month 2

    C-reactive protein level

  82. Inflammation

    Time frame: Month 3

    C-reactive protein level

  83. Inflammation

    Time frame: Month 4

    C-reactive protein level

  84. Inflammation

    Time frame: Month 5

    C-reactive protein level

  85. Inflammation

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    C-reactive protein level

  86. Activated partial thromboplastin time

    Time frame: Day 0

    seconds

  87. Activated partial thromboplastin time

    Time frame: Month 1

    seconds

  88. Activated partial thromboplastin time

    Time frame: Month 2

    seconds

  89. Activated partial thromboplastin time

    Time frame: Month 3

    seconds

  90. Activated partial thromboplastin time

    Time frame: Month 4

    seconds

  91. Activated partial thromboplastin time

    Time frame: Month 5

    seconds

  92. Activated partial thromboplastin time

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    seconds

  93. Prothrombin time

    Time frame: Day 0

    seconds

  94. Prothrombin time

    Time frame: Month 1

    seconds

  95. Prothrombin time

    Time frame: Month 2

    seconds

  96. Prothrombin time

    Time frame: Month 3

    seconds

  97. Prothrombin time

    Time frame: Month 4

    seconds

  98. Prothrombin time

    Time frame: Month 5

    seconds

  99. Prothrombin time

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    seconds

  100. Fibrinogen level

    Time frame: Day 0

    g/L

  101. Fibrinogen level

    Time frame: Month 1

    g/L

  102. Fibrinogen level

    Time frame: Month 2

    g/L

  103. Fibrinogen level

    Time frame: Month 3

    g/L

  104. Fibrinogen level

    Time frame: Month 4

    g/L

  105. Fibrinogen level

    Time frame: Month 5

    g/L

  106. Fibrinogen level

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    g/L

  107. Thrombin generation time

    Time frame: Month 1

    seconds

  108. Thrombin generation time

    Time frame: Month 2

    seconds

  109. Thrombin generation time

    Time frame: Month 3

    seconds

  110. Thrombin generation time

    Time frame: Month 4

    seconds

  111. Thrombin generation time

    Time frame: Month 5

    seconds

  112. Thrombin generation time

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    seconds

  113. Thrombin generation time

    Time frame: Day 0

    seconds

  114. fetal haemoglobin

    Time frame: Month 1

    g/L

  115. fetal haemoglobin

    Time frame: Month 2

    g/L

  116. fetal haemoglobin

    Time frame: Month 3

    g/L

  117. fetal haemoglobin

    Time frame: Month 4

    g/L

  118. fetal haemoglobin

    Time frame: Month 5

    g/L

  119. fetal haemoglobin

    Time frame: Delivery plus or minus 2 weeks (Month 6)

    g/L

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: GROSSAUTOP

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2020
Registry last updated
Dec 31, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.