Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-04 @ 10:23 AM
Study NCT ID:
NCT03354832
Status:
TERMINATED
Last Update Posted:
2019-03-07
First Post:
2017-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-utero Death and Birth Mortality in Reunion Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066088', 'term': 'Infant Death'}], 'ancestors': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003267', 'term': 'Contraception'}], 'ancestors': [{'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'small number of utero death, mothers refused to participate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of suboptimal care', 'timeFrame': 'within 4 weeks after birth (control) or lost (case)', 'description': 'The main suboptimal care are searched:\n\n* lack or inefficient corticotherapy during pregnancy\n* infant birth in an under equipped hospital, without facilities for premature birth\n* prenatal diagnosis of serious congenital malformations involving specific care at birth\n* lack of B-streptococcus detection\n* unexpected caesarean section during delivery\n* unexpected dystocia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Loss', 'Infant Death']}, 'descriptionModule': {'briefSummary': 'Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.', 'detailedDescription': 'Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.\n\nThis study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregant women or mother leaving in Reunion Island. Case and control women should have stay during all their pregancy and should have been admitted in an hospital in Reunion Island for delivery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)\n* Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital\n\nExclusion Criteria:\n\n* medical abortion\n* second pregnancy during the study period\n* case under forensic expertise'}, 'identificationModule': {'nctId': 'NCT03354832', 'acronym': 'RAMIR', 'briefTitle': 'In-utero Death and Birth Mortality in Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Research Action on Infant Mortality in Reunion Island Evaluation of Factors Affecting In-utero Foetal Death and New-born Death in Reunion Island', 'orgStudyIdInfo': {'id': '2016/CHU/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foetal death', 'description': 'In-utero dead foetus weighting at least 500 g or 22-amenorrhea weeks old. In utero death means that death occurs during delivery or per partum', 'interventionNames': ['Other: Foetal death']}, {'label': 'New-born death', 'description': 'New-born dead during post-birth hospital stay and at least 23-amenorrhea weeks old.', 'interventionNames': ['Other: New-born death']}, {'label': 'Birth control for foetal death', 'description': 'Same gender child born, and alive, in the same hospital, and born on time (37-41 amenorrhea weeks old).', 'interventionNames': ['Other: Birth control for foetal death']}, {'label': 'Birth control for new-born death', 'description': 'Same gender infant born, and alive, in the same hospital, and:\n\n* for 23-amenorrhea weeks old new-born death: control new-born are born on time (37-41 amenorrhea weeks old).\n* for 24 to 31-amenorrhea weeks old new-born death: control new-born are premature infant (24-31 amenorrhea weeks old), and are included when their hospital stay ends.\n* for 32 and more-amenorrhea weeks old new-born death: control new-born are 32 and more-amenorrhea weeks old infant', 'interventionNames': ['Other: Birth control for new-born death']}], 'interventions': [{'name': 'Foetal death', 'type': 'OTHER', 'description': 'A midwife is in charge to interview the mother during the month following the lost of her infant.', 'armGroupLabels': ['Foetal death']}, {'name': 'New-born death', 'type': 'OTHER', 'description': 'A midwife is in charge to interview the mother during the month following the lost of her infant.', 'armGroupLabels': ['New-born death']}, {'name': 'Birth control for foetal death', 'type': 'OTHER', 'description': 'A midwife is in charge to interview the mother during her hospital stay', 'armGroupLabels': ['Birth control for foetal death']}, {'name': 'Birth control for new-born death', 'type': 'OTHER', 'description': 'A midwife is in charge to interview the mother during her hospital stay', 'armGroupLabels': ['Birth control for new-born death']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97410', 'city': 'Saint-Pierre', 'country': 'Reunion', 'facility': 'Chu Reunion Island', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'overallOfficials': [{'name': 'Jean-Bernard GOUYON, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hpospitalier Universitaire de La REUNION'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}