<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443660</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2019-01/SB-01</org_study_id>
    <nct_id>NCT04443660</nct_id>
  </id_info>
  <brief_title>Autophagy/Apoptosis Balance During Pregnancy</brief_title>
  <acronym>GROSSAUTOP</acronym>
  <official_title>Autophagy/Apoptosis Balance During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The object of this study is to assess the intra- and inter-individual variability of&#xD;
      apoptosis and autophagy activities in women during pregnancy: 1 / in women with a normal&#xD;
      pregnancy and 2 / in pregnant women particularly at risk of complications.&#xD;
&#xD;
      The study investigators hypothesize that there would be an intra-trophoblastic dialogue&#xD;
      between the mechanisms of autophagy and apoptosis, the promotion of one partially inhibiting&#xD;
      the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an&#xD;
      anti-apoptosis defense phenomenon, the exhaustion of which would lead to cellular apoptosis&#xD;
      and to pathogenic consequences when it devastates the syncytiotrophoblast.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Day 0</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Month 1</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Month 2</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Month 3</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Month 4</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Month 5</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential autophagy induction activity in all groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Day 0</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Month 1</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Month 2</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Month 3</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Month 4</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Month 5</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of autophagy inhibition per patient in all groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Day 0</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Month 1</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Month 2</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Month 3</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Month 4</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Month 5</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential apoptosis induction activity in all groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>% cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Month 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Month 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Month 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Month 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-individual apoptosis/autophagy ratio in all groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Day 0</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Month 1</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Month 2</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Month 3</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Month 4</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Month 5</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autophagy kinetics between groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Day 0</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Month 1</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Month 2</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Month 3</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Month 4</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Month 5</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis kinetics between groups</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>measured by % cells positive for Annexin V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Day 0</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Month 1</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Month 2</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Month 3</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Month 4</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Month 5</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Growth Factor in each group</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Day 0</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Month 1</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Month 2</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Month 3</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Month 4</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Month 5</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble fms-like tyrosine kinase-1</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>pg/ml measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constitutive thrombophilia</measure>
    <time_frame>Day 0</time_frame>
    <description>presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Day 0</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Month 1</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Month 2</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Month 3</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Month 4</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Month 5</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acquired thrombophilia</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Month 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Month 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Month 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Month 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole blood count</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Day 0</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Month 1</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Month 2</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Month 3</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Month 4</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Month 5</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>creatinemia, proteinuria / creatinuria ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Day 0</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Month 1</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Month 2</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Month 3</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Month 4</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Month 5</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrin levels</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>D dimers and fibrin monomers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Day 0</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Month 1</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Month 2</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Month 3</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Month 4</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Month 5</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>C-reactive protein level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Day 0</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Month 1</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Month 2</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Month 3</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Month 4</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Month 5</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Day 0</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Month 1</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Month 2</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Month 3</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Month 4</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Month 5</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Day 0</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Month 1</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Month 2</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Month 3</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Month 4</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Month 5</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen level</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Month 1</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Month 2</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Month 3</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Month 4</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Month 5</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin generation time</measure>
    <time_frame>Day 0</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Month 1</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Month 2</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Month 3</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Month 4</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Month 5</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal haemoglobin</measure>
    <time_frame>Delivery plus or minus 2 weeks (Month 6)</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>without medical history or risk factors, with a normal pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>without medical history or risk factors, developing a pregnancy complication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>with risk of complication, having a normal pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>with a risk of complication, developing a pregnancy complication</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>Blood samples taken to test levels of autophagy and apoptosis</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, serum and mononuclear blood cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women followed at the Nîmes University Hospital for their pregnancy. Patients&#xD;
        will be recruited among those consulting hospital gynecologists from the 3rd month of&#xD;
        pregnancy but also through the circuit of specific gynecology-obstetrics consultations&#xD;
        receiving in particular women with a history and / or risk factors for pathological&#xD;
        pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients followed at the CHU Nîmes prior to 33 weeks gestation who give birth at the&#xD;
             hospital&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in a category 1 interventional study associated with a&#xD;
             medication, or is in a period of exclusion determined by a previous study&#xD;
&#xD;
          -  The subject refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  The patient is under safeguard of justice or state guardianship&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie Bouvier</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nimes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvie Bouvier</last_name>
    <phone>04.66.68.32.11</phone>
    <email>sylvie.bouvier@chu-nimes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anissa Megzari</last_name>
      <phone>04.66.68.42.36</phone>
      <email>drc@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Sylvie Bouvier</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Christophe Gris</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eve Mousty</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent Letouzey</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hélène Martin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie Porte</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marine Commissaire</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erick Mercier</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eva Nouvellon</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autophagy</keyword>
  <keyword>Apoptosis</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443660
org study id: NIMAO/2019-01/SB-01
nct id: NCT04443660
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Potential autophagy induction activity in all groups
time frame: Day 0
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Month 1
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Month 2
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Month 3
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Month 4
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Month 5
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential autophagy induction activity in all groups
time frame: Delivery plus or minus 2 weeks (Month 6)
description: Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Day 0
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Month 1
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Month 2
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Month 3
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Month 4
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Month 5
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Type of autophagy inhibition per patient in all groups
time frame: Delivery plus or minus 2 weeks (Month 6)
description: Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Potential apoptosis induction activity in all groups
time frame: Day 0
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Month 1
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Month 2
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Month 3
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Month 4
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Month 5
description: % cells positive for Annexin V
measure: Potential apoptosis induction activity in all groups
time frame: Delivery plus or minus 2 weeks (Month 6)
description: % cells positive for Annexin V
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Day 0
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Month 1
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Month 2
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Month 3
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Month 4
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Month 5
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
time frame: Delivery plus or minus 2 weeks (Month 6)
measure: Autophagy kinetics between groups
time frame: Day 0
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Month 1
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Month 2
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Month 3
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Month 4
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Month 5
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Autophagy kinetics between groups
time frame: Delivery plus or minus 2 weeks (Month 6)
description: measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
measure: Apoptosis kinetics between groups
time frame: Day 0
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Month 1
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Month 2
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Month 3
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Month 4
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Month 5
description: measured by % cells positive for Annexin V
measure: Apoptosis kinetics between groups
time frame: Delivery plus or minus 2 weeks (Month 6)
description: measured by % cells positive for Annexin V
measure: Placental Growth Factor in each group
time frame: Day 0
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Month 1
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Month 2
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Month 3
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Month 4
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Month 5
description: pg/ml measured by ELISA
measure: Placental Growth Factor in each group
time frame: Delivery plus or minus 2 weeks (Month 6)
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Day 0
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Month 1
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Month 2
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Month 3
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Month 4
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Month 5
description: pg/ml measured by ELISA
measure: Soluble fms-like tyrosine kinase-1
time frame: Delivery plus or minus 2 weeks (Month 6)
description: pg/ml measured by ELISA
measure: Constitutive thrombophilia
time frame: Day 0
description: presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency
measure: Acquired thrombophilia
time frame: Day 0
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Month 1
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Month 2
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Month 3
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Month 4
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Month 5
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Acquired thrombophilia
time frame: Delivery plus or minus 2 weeks (Month 6)
description: Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
measure: Whole blood count
time frame: Day 0
measure: Whole blood count
time frame: Month 1
measure: Whole blood count
time frame: Month 2
measure: Whole blood count
time frame: Month 3
measure: Whole blood count
time frame: Month 4
measure: Whole blood count
time frame: Month 5
measure: Whole blood count
time frame: Delivery plus or minus 2 weeks (Month 6)
measure: Renal function
time frame: Day 0
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Month 1
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Month 2
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Month 3
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Month 4
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Month 5
description: creatinemia, proteinuria / creatinuria ratio
measure: Renal function
time frame: Delivery plus or minus 2 weeks (Month 6)
description: creatinemia, proteinuria / creatinuria ratio
measure: Fibrin levels
time frame: Day 0
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Month 1
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Month 2
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Month 3
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Month 4
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Month 5
description: D dimers and fibrin monomers
measure: Fibrin levels
time frame: Delivery plus or minus 2 weeks (Month 6)
description: D dimers and fibrin monomers
measure: Inflammation
time frame: Day 0
description: C-reactive protein level
measure: Inflammation
time frame: Month 1
description: C-reactive protein level
measure: Inflammation
time frame: Month 2
description: C-reactive protein level
measure: Inflammation
time frame: Month 3
description: C-reactive protein level
measure: Inflammation
time frame: Month 4
description: C-reactive protein level
measure: Inflammation
time frame: Month 5
description: C-reactive protein level
measure: Inflammation
time frame: Delivery plus or minus 2 weeks (Month 6)
description: C-reactive protein level
measure: Activated partial thromboplastin time
time frame: Day 0
description: seconds
measure: Activated partial thromboplastin time
time frame: Month 1
description: seconds
measure: Activated partial thromboplastin time
time frame: Month 2
description: seconds
measure: Activated partial thromboplastin time
time frame: Month 3
description: seconds
measure: Activated partial thromboplastin time
time frame: Month 4
description: seconds
measure: Activated partial thromboplastin time
time frame: Month 5
description: seconds
measure: Activated partial thromboplastin time
time frame: Delivery plus or minus 2 weeks (Month 6)
description: seconds
measure: Prothrombin time
time frame: Day 0
description: seconds
measure: Prothrombin time
time frame: Month 1
description: seconds
measure: Prothrombin time
time frame: Month 2
description: seconds
measure: Prothrombin time
time frame: Month 3
description: seconds
measure: Prothrombin time
time frame: Month 4
description: seconds
measure: Prothrombin time
time frame: Month 5
description: seconds
measure: Prothrombin time
time frame: Delivery plus or minus 2 weeks (Month 6)
description: seconds
measure: Fibrinogen level
time frame: Day 0
description: g/L
measure: Fibrinogen level
time frame: Month 1
description: g/L
measure: Fibrinogen level
time frame: Month 2
description: g/L
measure: Fibrinogen level
time frame: Month 3
description: g/L
measure: Fibrinogen level
time frame: Month 4
description: g/L
measure: Fibrinogen level
time frame: Month 5
description: g/L
measure: Fibrinogen level
time frame: Delivery plus or minus 2 weeks (Month 6)
description: g/L
measure: Thrombin generation time
time frame: Month 1
description: seconds
measure: Thrombin generation time
time frame: Month 2
description: seconds
measure: Thrombin generation time
time frame: Month 3
description: seconds
measure: Thrombin generation time
time frame: Month 4
description: seconds
measure: Thrombin generation time
time frame: Month 5
description: seconds
measure: Thrombin generation time
time frame: Delivery plus or minus 2 weeks (Month 6)
description: seconds
measure: Thrombin generation time
time frame: Day 0
description: seconds
measure: fetal haemoglobin
time frame: Month 1
description: g/L
measure: fetal haemoglobin
time frame: Month 2
description: g/L
measure: fetal haemoglobin
time frame: Month 3
description: g/L
measure: fetal haemoglobin
time frame: Month 4
description: g/L
measure: fetal haemoglobin
time frame: Month 5
description: g/L
measure: fetal haemoglobin
time frame: Delivery plus or minus 2 weeks (Month 6)
description: g/L
arm group label: Group A
description: without medical history or risk factors, with a normal pregnancy
arm group label: Group B
description: without medical history or risk factors, developing a pregnancy complication
arm group label: Group C
description: with risk of complication, having a normal pregnancy
arm group label: Group D
description: with a risk of complication, developing a pregnancy complication
intervention type: Other
intervention name: Blood test
description: Blood samples taken to test levels of autophagy and apoptosis
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
Plasma, serum and mononuclear blood cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvie Bouvier
role: Principal Investigator
affiliation: CHU Nimes
last name: Sylvie Bouvier
phone: 04.66.68.32.11
email: sylvie.bouvier@chu-nimes.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor