Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-04-13 @ 9:33 PM
Study NCT ID:
NCT03920332
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Fibrinogen Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000347', 'term': 'Afibrinogenemia'}, {'id': 'C562727', 'term': 'Dysfibrinogenemia, Congenital'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of normal issue pregnancy', 'timeFrame': 'At inclusion', 'description': 'All pregnancy not resulting in miscarriage, stillbirth or abortion'}], 'secondaryOutcomes': [{'measure': 'Prevalence of pregnancy without complications', 'timeFrame': 'At inclusion', 'description': 'All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention'}, {'measure': 'Modalities of delivery', 'timeFrame': 'At inclusion', 'description': 'Vaginal versus caesarean cut'}, {'measure': 'Modalities of delivery', 'timeFrame': 'At inclusion', 'description': 'Instrumental delivery vs none'}, {'measure': 'Post-partum complications', 'timeFrame': 'At inclusion', 'description': 'Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery'}, {'measure': 'Fibrinogen variations', 'timeFrame': 'At inclusion', 'description': 'Fibrinogen levels throughout the pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'obstetric', 'miscarriage', 'haemorrhage', 'fibrinogen'], 'conditions': ['Hypofibrinogenemia, Congenital', 'Afibrinogenemia, Congenital', 'Dysfibrinogenemia, Congenital']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.', 'detailedDescription': "Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women will be recruited in Hemophilia Centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)\n* At lest one past pregnancy\n* Adult\n\nExclusion Criteria:\n\n* No past pregnancy\n* Not confirmed fibrinogen disorder'}, 'identificationModule': {'nctId': 'NCT03920332', 'acronym': 'FIBRINOGEST', 'briefTitle': 'Pregnancy and Fibrinogen Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders', 'orgStudyIdInfo': {'id': 'CCER2019-00353'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Port-Royal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Jessenius Faculty of Medicine and University Hospital', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Alessandro Casini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Geneva'}, {'name': 'Justine Hugon-Rodin, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Hemophilia Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal Investigator', 'investigatorFullName': 'Casini Alessandro', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}