Autophagy/Apoptosis Balance During Pregnancy

Pregnancy Related Clinical Trial

— GROSSAUTOP  

Official title:

Autophagy/Apoptosis Balance During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443660
• Other study ID #: NIMAO/2019-01/SB-01
• Status: Recruiting
• Start date: December 30, 2020
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Sylvie Bouvier
• Phone: 04.66.68.32.11
• Email: sylvie.bouvier[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Blood test
Blood samples taken to test levels of autophagy and apoptosis

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Day 0
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 1
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 2
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 3
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 4
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 5
Primary	Potential autophagy induction activity in all groups	Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Delivery plus or minus 2 weeks (Month 6)
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Day 0
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 1
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 2
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 3
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 4
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 5
Secondary	Type of autophagy inhibition per patient in all groups	Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Delivery plus or minus 2 weeks (Month 6)
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Day 0
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Month 1
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Month 2
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Month 3
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Month 4
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Month 5
Secondary	Potential apoptosis induction activity in all groups	% cells positive for Annexin V	Delivery plus or minus 2 weeks (Month 6)
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Day 0
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Month 1
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Month 2
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Month 3
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Month 4
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Month 5
Secondary	Inter- and intra-individual apoptosis/autophagy ratio in all groups		Delivery plus or minus 2 weeks (Month 6)
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Day 0
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 1
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 2
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 3
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 4
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Month 5
Secondary	Autophagy kinetics between groups	measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio	Delivery plus or minus 2 weeks (Month 6)
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Day 0
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Month 1
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Month 2
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Month 3
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Month 4
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Month 5
Secondary	Apoptosis kinetics between groups	measured by % cells positive for Annexin V	Delivery plus or minus 2 weeks (Month 6)
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Day 0
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Month 1
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Month 2
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Month 3
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Month 4
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Month 5
Secondary	Placental Growth Factor in each group	pg/ml measured by ELISA	Delivery plus or minus 2 weeks (Month 6)
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Day 0
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Month 1
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Month 2
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Month 3
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Month 4
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Month 5
Secondary	Soluble fms-like tyrosine kinase-1	pg/ml measured by ELISA	Delivery plus or minus 2 weeks (Month 6)
Secondary	Constitutive thrombophilia	presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency	Day 0
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Day 0
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Month 1
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Month 2
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Month 3
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Month 4
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Month 5
Secondary	Acquired thrombophilia	Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).	Delivery plus or minus 2 weeks (Month 6)
Secondary	Whole blood count		Day 0
Secondary	Whole blood count		Month 1
Secondary	Whole blood count		Month 2
Secondary	Whole blood count		Month 3
Secondary	Whole blood count		Month 4
Secondary	Whole blood count		Month 5
Secondary	Whole blood count		Delivery plus or minus 2 weeks (Month 6)
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Day 0
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Month 1
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Month 2
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Month 3
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Month 4
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Month 5
Secondary	Renal function	creatinemia, proteinuria / creatinuria ratio	Delivery plus or minus 2 weeks (Month 6)
Secondary	Fibrin levels	D dimers and fibrin monomers	Day 0
Secondary	Fibrin levels	D dimers and fibrin monomers	Month 1
Secondary	Fibrin levels	D dimers and fibrin monomers	Month 2
Secondary	Fibrin levels	D dimers and fibrin monomers	Month 3
Secondary	Fibrin levels	D dimers and fibrin monomers	Month 4
Secondary	Fibrin levels	D dimers and fibrin monomers	Month 5
Secondary	Fibrin levels	D dimers and fibrin monomers	Delivery plus or minus 2 weeks (Month 6)
Secondary	Inflammation	C-reactive protein level	Day 0
Secondary	Inflammation	C-reactive protein level	Month 1
Secondary	Inflammation	C-reactive protein level	Month 2
Secondary	Inflammation	C-reactive protein level	Month 3
Secondary	Inflammation	C-reactive protein level	Month 4
Secondary	Inflammation	C-reactive protein level	Month 5
Secondary	Inflammation	C-reactive protein level	Delivery plus or minus 2 weeks (Month 6)
Secondary	Activated partial thromboplastin time	seconds	Day 0
Secondary	Activated partial thromboplastin time	seconds	Month 1
Secondary	Activated partial thromboplastin time	seconds	Month 2
Secondary	Activated partial thromboplastin time	seconds	Month 3
Secondary	Activated partial thromboplastin time	seconds	Month 4
Secondary	Activated partial thromboplastin time	seconds	Month 5
Secondary	Activated partial thromboplastin time	seconds	Delivery plus or minus 2 weeks (Month 6)
Secondary	Prothrombin time	seconds	Day 0
Secondary	Prothrombin time	seconds	Month 1
Secondary	Prothrombin time	seconds	Month 2
Secondary	Prothrombin time	seconds	Month 3
Secondary	Prothrombin time	seconds	Month 4
Secondary	Prothrombin time	seconds	Month 5
Secondary	Prothrombin time	seconds	Delivery plus or minus 2 weeks (Month 6)
Secondary	Fibrinogen level	g/L	Day 0
Secondary	Fibrinogen level	g/L	Month 1
Secondary	Fibrinogen level	g/L	Month 2
Secondary	Fibrinogen level	g/L	Month 3
Secondary	Fibrinogen level	g/L	Month 4
Secondary	Fibrinogen level	g/L	Month 5
Secondary	Fibrinogen level	g/L	Delivery plus or minus 2 weeks (Month 6)
Secondary	Thrombin generation time	seconds	Month 1
Secondary	Thrombin generation time	seconds	Month 2
Secondary	Thrombin generation time	seconds	Month 3
Secondary	Thrombin generation time	seconds	Month 4
Secondary	Thrombin generation time	seconds	Month 5
Secondary	Thrombin generation time	seconds	Delivery plus or minus 2 weeks (Month 6)
Secondary	Thrombin generation time	seconds	Day 0
Secondary	fetal haemoglobin	g/L	Month 1
Secondary	fetal haemoglobin	g/L	Month 2
Secondary	fetal haemoglobin	g/L	Month 3
Secondary	fetal haemoglobin	g/L	Month 4
Secondary	fetal haemoglobin	g/L	Month 5
Secondary	fetal haemoglobin	g/L	Delivery plus or minus 2 weeks (Month 6)