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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04443660
Other study ID # NIMAO/2019-01/SB-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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