Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-10 @ 10:08 PM
Study NCT ID:
NCT01610258
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2012-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}, {'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2016-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the percentage of Treg in maternal blood at the time of admission', 'timeFrame': 'the day of delivery or 7 days after the admission if no delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy, chorioamnionitis, PPROM, Treg'], 'conditions': ['Pathology of Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.', 'detailedDescription': 'Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.\n\nMoreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.\n\nRecent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.\n\nIn case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.\n\nIn this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed\n* Patient affiliated with a social security scheme\n* term pregnancy betwwen 24 and 34 weeks\n* PPROM diagnosis\n* singleton pregnancy\n\nExclusion Criteria:\n\n* delivery occured in 1 hour after admission\n* hemorragic praevia placenta or retro-placental hematoma\n* confirmed autoimmune or inflammatory disease\n* confirmed infectious disease by VIH, VHC, and VHB'}, 'identificationModule': {'nctId': 'NCT01610258', 'acronym': 'ICAR', 'briefTitle': 'Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks', 'orgStudyIdInfo': {'id': 'BARDOU-PHRC-2011'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood and placenta samples', 'type': 'OTHER', 'description': 'The placenta sample is realised, specially for the study, in surgical unit after the delivery.\n\nThe blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'Maternité du CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}