Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-28 @ 4:50 PM
Study NCT ID:
NCT05188066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-01-12
First Post:
2021-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pregnancy Pathologies Associated With Placental Abnormalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008679', 'term': 'Metaplasia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016626', 'term': 'Shadowing Technique, Histology'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Placenta and fetal membrane from normal and pathological pregnancies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2021-12-18', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To better characterize pregnancy pathologies from implantation to childbirth', 'timeFrame': 'Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours', 'description': 'Comparison of the frequencies (in percentage) of the histological differences of the placenta and its appendages in patients with pathological and normal pregnancies (histological differences of normal pregnancies versus pathological pregnancies.'}], 'secondaryOutcomes': [{'measure': 'Link between the frequencies of histological aberrations and worsening of the pathology', 'timeFrame': 'Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.', 'description': 'Comparison of the severity of the pathology according to the frequencies of aberrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-eclampsia', 'fetal growth retardation', 'placenta histology', 'vascularization', 'trophoblast proliferation'], 'conditions': ['Pre-eclampsia', 'Pre-Term', 'Fetal Growth Retardation']}, 'descriptionModule': {'briefSummary': 'Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them.\n\nThe investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.', 'detailedDescription': 'Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.\n\nThe investigators need to collect samples, especially placental samples, following abortions, term, and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for understanding the histological changes that occur in normal placentas collected at term of pregnancy. The latter, will in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.\n\nThe investigators are internationally recognized for its research on these thematic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include normal and pathological pregnant women from first to third trimester. A finaliser', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult women\n\n* Admitted to the CHUGA for a birth or an abortion.\n* Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.\n* Having signed a consent\n* Affiliated with social security\n\nExclusion Criteria:\n\n* Placental sample or abortion product unavailable (not collected or necessary for treatment).\n* Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.\n* hemoglobin \\<7d / dL or hemoglobin \\<10g / dL if she suffers from a cardio-respiratory pathology).\n* Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)'}, 'identificationModule': {'nctId': 'NCT05188066', 'briefTitle': 'Study of Pregnancy Pathologies Associated With Placental Abnormalities', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Study of Pregnancy Pathologies Associated With Placental Abnormalities', 'orgStudyIdInfo': {'id': '38RC20.115'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal, pathological IVG', 'description': 'We will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG.', 'interventionNames': ['Diagnostic Test: Histology']}, {'label': 'Normal and pathological term', 'description': 'We will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser', 'interventionNames': ['Diagnostic Test: Histology']}], 'interventions': [{'name': 'Histology', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['immunohistochemistry'], 'description': 'Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses', 'armGroupLabels': ['Normal and pathological term', 'Normal, pathological IVG']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pascale Hoffmann, MD PhD', 'role': 'CONTACT', 'email': 'PHoffmann@chu-grenoble.fr', 'phone': '0476769223'}, {'name': 'Nadia Alfaidy, PhD', 'role': 'CONTACT', 'email': 'nadia.alfaidy-benharouga@cea.fr', 'phone': '0033632073234'}], 'overallOfficials': [{'name': 'Pascale Hoffmann, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble hospital'}, {'name': 'Nadia Alfaidy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSERM U1292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}