Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT04443660
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autophagy/Apoptosis Balance During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum and mononuclear blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Day 0', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Month 1', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Month 2', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Month 3', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Month 4', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Month 5', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Potential autophagy induction activity in all groups', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}], 'secondaryOutcomes': [{'measure': 'Type of autophagy inhibition per patient in all groups', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': 'Day 0', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': 'Month 1', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': 'Month 2', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': 'Month 3', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': 'Month 4', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': 'Month 5', 'description': '% cells positive for Annexin V'}, {'measure': 'Potential apoptosis induction activity in all groups', 'timeFrame': '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', 'timeFrame': 'Day 0'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Month 1'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Month 2'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Month 3'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Month 4'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Month 5'}, {'measure': 'Inter- and intra-individual apoptosis/autophagy ratio in all groups', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Day 0', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Month 1', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Month 2', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Month 3', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Month 4', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': 'Month 5', 'description': 'measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio'}, {'measure': 'Autophagy kinetics between groups', 'timeFrame': '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', 'timeFrame': 'Day 0', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Month 1', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Month 2', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Month 3', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Month 4', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Month 5', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Apoptosis kinetics between groups', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'measured by % cells positive for Annexin V'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Day 0', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Month 1', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Month 2', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Month 3', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Month 4', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Month 5', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Placental Growth Factor in each group', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Day 0', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Month 1', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Month 2', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Month 3', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Month 4', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Month 5', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Soluble fms-like tyrosine kinase-1', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'pg/ml measured by ELISA'}, {'measure': 'Constitutive thrombophilia', 'timeFrame': 'Day 0', 'description': 'presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Day 0', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Month 1', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Month 2', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Month 3', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Month 4', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': 'Month 5', 'description': 'Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).'}, {'measure': 'Acquired thrombophilia', 'timeFrame': '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', 'timeFrame': 'Day 0'}, {'measure': 'Whole blood count', 'timeFrame': 'Month 1'}, {'measure': 'Whole blood count', 'timeFrame': 'Month 2'}, {'measure': 'Whole blood count', 'timeFrame': 'Month 3'}, {'measure': 'Whole blood count', 'timeFrame': 'Month 4'}, {'measure': 'Whole blood count', 'timeFrame': 'Month 5'}, {'measure': 'Whole blood count', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)'}, {'measure': 'Renal function', 'timeFrame': 'Day 0', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Month 1', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Month 2', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Month 3', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Month 4', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Month 5', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Renal function', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'creatinemia, proteinuria / creatinuria ratio'}, {'measure': 'Fibrin levels', 'timeFrame': 'Day 0', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Month 1', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Month 2', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Month 3', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Month 4', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Month 5', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Fibrin levels', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'D dimers and fibrin monomers'}, {'measure': 'Inflammation', 'timeFrame': 'Day 0', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Month 1', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Month 2', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Month 3', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Month 4', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Month 5', 'description': 'C-reactive protein level'}, {'measure': 'Inflammation', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'C-reactive protein level'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Day 0', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Month 1', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Month 2', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Month 3', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Month 4', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Month 5', 'description': 'seconds'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Day 0', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Month 1', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Month 2', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Month 3', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Month 4', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Month 5', 'description': 'seconds'}, {'measure': 'Prothrombin time', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'seconds'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Day 0', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Month 1', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Month 2', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Month 3', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Month 4', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Month 5', 'description': 'g/L'}, {'measure': 'Fibrinogen level', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'g/L'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Month 1', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Month 2', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Month 3', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Month 4', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Month 5', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'seconds'}, {'measure': 'Thrombin generation time', 'timeFrame': 'Day 0', 'description': 'seconds'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Month 1', 'description': 'g/L'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Month 2', 'description': 'g/L'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Month 3', 'description': 'g/L'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Month 4', 'description': 'g/L'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Month 5', 'description': 'g/L'}, {'measure': 'fetal haemoglobin', 'timeFrame': 'Delivery plus or minus 2 weeks (Month 6)', 'description': 'g/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autophagy', 'Apoptosis'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women followed at the Nimes University Hospital for their pregnancy. Patients will be recruited among those consulting hospital gynecologists from the 3rd month of pregnancy but also through the circuit of specific gynecology-obstetrics consultations receiving in particular women with a history and / or risk factors for pathological pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients followed at the CHU Nimes prior to 33 weeks gestation who give birth at the hospital\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* 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\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT04443660', 'acronym': 'GROSSAUTOP', 'briefTitle': 'Autophagy/Apoptosis Balance During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Autophagy/Apoptosis Balance During Pregnancy', 'orgStudyIdInfo': {'id': 'NIMAO/2019-01/SB-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'without medical history or risk factors, with a normal pregnancy', 'interventionNames': ['Other: Blood test']}, {'label': 'Group B', 'description': 'without medical history or risk factors, developing a pregnancy complication', 'interventionNames': ['Other: Blood test']}, {'label': 'Group C', 'description': 'with risk of complication, having a normal pregnancy', 'interventionNames': ['Other: Blood test']}, {'label': 'Group D', 'description': 'with a risk of complication, developing a pregnancy complication', 'interventionNames': ['Other: Blood test']}], 'interventions': [{'name': 'Blood test', 'type': 'OTHER', 'description': 'Blood samples taken to test levels of autophagy and apoptosis', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Sylvie Bouvier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}