Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-26 @ 10:44 PM
Study NCT ID:
NCT06889727
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2025-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of pregnancies in women with beta thalassemia followed in Italian centres', 'timeFrame': '15 YEARS', 'description': 'To evaluate the number of pregnancies in women with beta thalassemia followed in Italian centres and how the increase in the average age of the thalassemia population impact on the number of new pregnancies over time'}, {'measure': 'number of pregnancies spontaneously', 'timeFrame': '15 YEARS', 'description': 'many pregnancies occurred spontaneously'}, {'measure': 'number of pregnancies after hormonal stimulation', 'timeFrame': '15 YEARS', 'description': 'number of pregnancies after hormonal stimulation'}, {'measure': 'likelihood of miscarriage', 'timeFrame': '15 YEARS', 'description': 'To evaluate the likelihood of miscarriage'}, {'measure': 'foetal death', 'timeFrame': '15 YEARS', 'description': 'To evaluate foetal death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thalassemia']}, 'descriptionModule': {'briefSummary': 'Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'FEMALE THALASSEMIE DEPEND TRANSFUSION', 'genderDescription': 'FEMALE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transfusion dependent and nontransfusion- dependent thalassemia\n* Pregnancy ended with the birth of a live or dead foetus\n* Pregnancy ended in miscarriage or voluntary abortion\n* Pregnancy in progress\n\nExclusion Criteria:\n\n* Other types of anemia\n* Pregnancy not initiated despite assisted fertilization practices\n* Subjects unwilling to sign informed consent'}, 'identificationModule': {'nctId': 'NCT06889727', 'briefTitle': 'Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia'}, 'officialTitle': 'Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study', 'orgStudyIdInfo': {'id': 'GRAV001'}}, 'contactsLocationsModule': {'locations': [{'zip': '09123', 'city': 'Cagliari', 'state': 'CAGLIARI', 'country': 'Italy', 'facility': 'UniversityCagliari, OspPed Microcitemico, Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}