Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06480916
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of "avoidable" maternal-foetal transfer (MFT)', 'timeFrame': 'after delivery, up to 6 weeks after the maternal-foetal transfer', 'description': 'The main evaluation criterion is "avoidable" maternal-foetal transfer (MFT), i.e. resulting in a delivery that met the acceptance criteria of the original maternity hospital'}], 'secondaryOutcomes': [{'measure': 'Obstetrical indication for maternal-foetal transfer (MFT)', 'timeFrame': 'Up to 48 hours after the maternal-foetal transfer', 'description': 'as documented in the patient file'}, {'measure': 'Organizational arrangements for maternal-foetal transfer', 'timeFrame': 'Up to 6 months after inclusion of a maternity unit in the study', 'description': 'Organizational arrangements for maternal-foetal transfer in the various centers, assessed by a specific questionnaire sent to maternity units.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maternal-fetal transfer', 'care organization', 'patient pathway', 'maternity hospital'], 'conditions': ['Maternal-Fetal Relations']}, 'descriptionModule': {'briefSummary': 'It is an observational, descriptive, prospective, multicenter study of 8 maternity units in Lorraine and Champagne-Ardenne, aimed at comparing the percentage of "avoidable" maternal-fetal transfers (MFTs), defined as transfers in which the delivery finally meets the acceptance criteria of the sending maternity unit, according to the obstetrical indications for these MFTs.', 'detailedDescription': "Over the past year, an audit carried out on the Mercy maternity unit, covering 130 transfers to the Nancy regional maternity hospital, showed that patients transferred for threat of premature delivery (MAP) with a cervix \\> 15 mm do not give birth at the receiving maternity unit, but return home after 48 hours' hospitalization.\n\nWhen maternal-fetal transfer (MFT) is requested, numerous calls are made to private ambulance services, and in the end, many emergency rapid response units (SMUR) are called out, requiring a major human, logistical and time investment for a questionable benefit to the patient. Tensions in terms of logistics (lack of ambulance, SMUR) and human resources (lack of personnel) can, conversely, compromise good care of the parturient."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Maternal-fetal transfers (MFTs) for threatened premature delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman cared for in a participating maternity unit\n* Over 18 years of age\n* Requested for maternal-fetal transfer (finally performed, or not)\n\nExclusion Criteria:\n\n* missing data on transfer outcome'}, 'identificationModule': {'nctId': 'NCT06480916', 'acronym': 'TRANSFERT', 'briefTitle': 'Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation', 'orgStudyIdInfo': {'id': '2024-04Obs-CHRMT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Maternal-fetal transfers', 'type': 'PROCEDURE', 'description': 'Prospective and consecutive inclusion of all maternal-fetal transfers during the study period. The teams at the sending and receiving maternity units will complete study-related questionnaires to describe the conditions of the transfer and the outcome of the pregnancy. The study in no way alters the way parturients are cared for.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Briey', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Hayat AALALOU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Maillot', 'geoPoint': {'lat': 49.2492, 'lon': 5.93975}}, {'city': 'Châlons-en-Champagne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Aurore Pechereau', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maternité CH Léon Bourgeois', 'geoPoint': {'lat': 48.95393, 'lon': 4.36724}}, {'zip': '57085', 'city': 'Metz', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR, PhD', 'role': 'CONTACT', 'email': 'projet-recherche-clinique@chr-metz-thionville.fr', 'phone': '0033387557766'}, {'name': 'Laetitia HONORE-ROUGE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Metz Thionville Hopital Femme Mère Enfant', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Romilly-sur-Seine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Fares GHRAIRI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maternité - Hôpital Maurice Camuset', 'geoPoint': {'lat': 48.51085, 'lon': 3.72634}}, {'city': 'Saint-Avold', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Hélène MINEBOIS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Saint Nabor', 'geoPoint': {'lat': 49.10465, 'lon': 6.70402}}, {'city': 'Saint-Dizier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Hazem ALGUMAA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Matérnité Saint Dizier', 'geoPoint': {'lat': 48.63773, 'lon': 4.94892}}, {'city': 'Thionville', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT', 'email': 'projet-recherche-clinique@chr-metz-thionville.fr'}, {'name': 'Laurene MATUSZEWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Metz-Thionville Hopital Bel Air', 'geoPoint': {'lat': 49.35994, 'lon': 6.16044}}, {'city': 'Verdun', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT'}, {'name': 'Fabienne GALLEY-RAULIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Nicolas', 'geoPoint': {'lat': 49.15964, 'lon': 5.3829}}], 'centralContacts': [{'name': 'Arpiné EL NAR, PhD', 'role': 'CONTACT', 'email': 'projet-recherche-clinique@chr-metz-thionville.fr', 'phone': '0033387557766'}], 'overallOfficials': [{'name': 'Laetitia HONORE-ROUGE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital Femme Mère Enfant'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}