GROSSAUTOP: Autophagy/Apoptosis Balance During Pregnancy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A without medical history or risk factors, with a normal pregnancy |
Other: Blood test
Blood samples taken to test levels of autophagy and apoptosis
|
| Group B without medical history or risk factors, developing a pregnancy complication |
Other: Blood test
Blood samples taken to test levels of autophagy and apoptosis
|
| Group C with risk of complication, having a normal pregnancy |
Other: Blood test
Blood samples taken to test levels of autophagy and apoptosis
|
| Group D with a risk of complication, developing a pregnancy complication |
Other: Blood test
Blood samples taken to test levels of autophagy and apoptosis
|
Outcome Measures
Primary Outcome Measures
- Potential autophagy induction activity in all groups [Day 0]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Month 1]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Month 2]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Month 3]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Month 4]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Month 5]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential autophagy induction activity in all groups [Delivery plus or minus 2 weeks (Month 6)]
Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
Secondary Outcome Measures
- Type of autophagy inhibition per patient in all groups [Day 0]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Month 1]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Month 2]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Month 3]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Month 4]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Month 5]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Type of autophagy inhibition per patient in all groups [Delivery plus or minus 2 weeks (Month 6)]
Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Potential apoptosis induction activity in all groups [Day 0]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Month 1]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Month 2]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Month 3]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Month 4]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Month 5]
% cells positive for Annexin V
- Potential apoptosis induction activity in all groups [Delivery plus or minus 2 weeks (Month 6)]
% cells positive for Annexin V
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Day 0]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Month 1]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Month 2]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Month 3]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Month 4]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Month 5]
- Inter- and intra-individual apoptosis/autophagy ratio in all groups [Delivery plus or minus 2 weeks (Month 6)]
- Autophagy kinetics between groups [Day 0]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Month 1]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Month 2]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Month 3]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Month 4]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Month 5]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Autophagy kinetics between groups [Delivery plus or minus 2 weeks (Month 6)]
measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
- Apoptosis kinetics between groups [Day 0]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Month 1]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Month 2]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Month 3]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Month 4]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Month 5]
measured by % cells positive for Annexin V
- Apoptosis kinetics between groups [Delivery plus or minus 2 weeks (Month 6)]
measured by % cells positive for Annexin V
- Placental Growth Factor in each group [Day 0]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Month 1]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Month 2]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Month 3]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Month 4]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Month 5]
pg/ml measured by ELISA
- Placental Growth Factor in each group [Delivery plus or minus 2 weeks (Month 6)]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Day 0]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Month 1]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Month 2]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Month 3]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Month 4]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Month 5]
pg/ml measured by ELISA
- Soluble fms-like tyrosine kinase-1 [Delivery plus or minus 2 weeks (Month 6)]
pg/ml measured by ELISA
- Constitutive thrombophilia [Day 0]
presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency
- Acquired thrombophilia [Day 0]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [Month 1]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [Month 2]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [Month 3]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [Month 4]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [Month 5]
Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
- Acquired thrombophilia [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).
- Whole blood count [Day 0]
- Whole blood count [Month 1]
- Whole blood count [Month 2]
- Whole blood count [Month 3]
- Whole blood count [Month 4]
- Whole blood count [Month 5]
- Whole blood count [Delivery plus or minus 2 weeks (Month 6)]
- Renal function [Day 0]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Month 1]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Month 2]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Month 3]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Month 4]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Month 5]
creatinemia, proteinuria / creatinuria ratio
- Renal function [Delivery plus or minus 2 weeks (Month 6)]
creatinemia, proteinuria / creatinuria ratio
- Fibrin levels [Day 0]
D dimers and fibrin monomers
- Fibrin levels [Month 1]
D dimers and fibrin monomers
- Fibrin levels [Month 2]
D dimers and fibrin monomers
- Fibrin levels [Month 3]
D dimers and fibrin monomers
- Fibrin levels [Month 4]
D dimers and fibrin monomers
- Fibrin levels [Month 5]
D dimers and fibrin monomers
- Fibrin levels [Delivery plus or minus 2 weeks (Month 6)]
D dimers and fibrin monomers
- Inflammation [Day 0]
C-reactive protein level
- Inflammation [Month 1]
C-reactive protein level
- Inflammation [Month 2]
C-reactive protein level
- Inflammation [Month 3]
C-reactive protein level
- Inflammation [Month 4]
C-reactive protein level
- Inflammation [Month 5]
C-reactive protein level
- Inflammation [Delivery plus or minus 2 weeks (Month 6)]
C-reactive protein level
- Activated partial thromboplastin time [Day 0]
seconds
- Activated partial thromboplastin time [Month 1]
seconds
- Activated partial thromboplastin time [Month 2]
seconds
- Activated partial thromboplastin time [Month 3]
seconds
- Activated partial thromboplastin time [Month 4]
seconds
- Activated partial thromboplastin time [Month 5]
seconds
- Activated partial thromboplastin time [Delivery plus or minus 2 weeks (Month 6)]
seconds
- Prothrombin time [Day 0]
seconds
- Prothrombin time [Month 1]
seconds
- Prothrombin time [Month 2]
seconds
- Prothrombin time [Month 3]
seconds
- Prothrombin time [Month 4]
seconds
- Prothrombin time [Month 5]
seconds
- Prothrombin time [Delivery plus or minus 2 weeks (Month 6)]
seconds
- Fibrinogen level [Day 0]
g/L
- Fibrinogen level [Month 1]
g/L
- Fibrinogen level [Month 2]
g/L
- Fibrinogen level [Month 3]
g/L
- Fibrinogen level [Month 4]
g/L
- Fibrinogen level [Month 5]
g/L
- Fibrinogen level [Delivery plus or minus 2 weeks (Month 6)]
g/L
- Thrombin generation time [Month 1]
seconds
- Thrombin generation time [Month 2]
seconds
- Thrombin generation time [Month 3]
seconds
- Thrombin generation time [Month 4]
seconds
- Thrombin generation time [Month 5]
seconds
- Thrombin generation time [Delivery plus or minus 2 weeks (Month 6)]
seconds
- Thrombin generation time [Day 0]
seconds
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients followed at the CHU Nîmes 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nimes | Nîmes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Sylvie Bouvier, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2019-01/SB-01