Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT06758960
Status:
RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Biological Progression and Regression of HELLP Syndrome in Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017359', 'term': 'HELLP Syndrome'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D063130', 'term': 'Maternal Death'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-14', 'size': 114498, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-21T18:14', 'hasProtocol': True}, {'date': '2024-12-14', 'size': 104737, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-21T18:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-28', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelets count', 'timeFrame': 'Up to 10 days', 'description': 'Platelets count will be monitored daily before and after delivery'}], 'secondaryOutcomes': [{'measure': 'Concentration of Lactate dehydrogenase', 'timeFrame': 'Up to 10 days', 'description': 'Monitored daily before and after delivery'}, {'measure': 'Concentration of Liver enzymes', 'timeFrame': 'Up to 10 days', 'description': 'daily monitoring of alkaline phosphatase, alanine transaminase before and after delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'HELLP syndrome', 'Thrombocytopenia', 'Maternal mortality'], 'conditions': ['HELLP Syndrome', 'Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '2216215', 'type': 'BACKGROUND', 'citation': 'Martin JN Jr, Blake PG, Lowry SL, Perry KG Jr, Files JC, Morrison JC. Pregnancy complicated by preeclampsia-eclampsia with the syndrome of hemolysis, elevated liver enzymes, and low platelet count: how rapid is postpartum recovery? Obstet Gynecol. 1990 Nov;76(5 Pt 1):737-41. doi: 10.1097/00006250-199011000-00001.'}, {'pmid': '2048596', 'type': 'BACKGROUND', 'citation': 'Martin JN Jr, Blake PG, Perry KG Jr, McCaul JF, Hess LW, Martin RW. The natural history of HELLP syndrome: patterns of disease progression and regression. Am J Obstet Gynecol. 1991 Jun;164(6 Pt 1):1500-9; discussion 1509-13. doi: 10.1016/0002-9378(91)91429-z.'}]}, 'descriptionModule': {'briefSummary': 'Prospective observational study about progression and regression of biological parameters of HELLP syndrome', 'detailedDescription': 'Data collection included a comprehensive review of pathological histories, identification of complications based on clinical presentation, daily monitoring of biological parameters, documentation of transfusion events, recording of corticosteroid administration according to gestational age, and detailed reporting of extraction and analgesia techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh', 'genderDescription': 'FEMALE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome\n\nExclusion Criteria:\n\n* Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.\n* Patients who benefited from plasma exchange therapy'}, 'identificationModule': {'nctId': 'NCT06758960', 'briefTitle': 'Analysis of Biological Progression and Regression of HELLP Syndrome in Time', 'organization': {'class': 'OTHER', 'fullName': 'CHU Mohammed VI Marrakech'}, 'officialTitle': 'Biological Evolution of HELLP Syndrome', 'orgStudyIdInfo': {'id': '67/2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '40000', 'city': 'Marrakesh', 'state': 'Marrakech - Safi', 'status': 'RECRUITING', 'country': 'Morocco', 'contacts': [{'name': 'Nizar Amllah, M.D', 'role': 'CONTACT', 'email': 'nizaramllah@gmail.com', 'phone': '+212 613069684'}], 'facility': 'CHU Mohammed VI of Marrakech', 'geoPoint': {'lat': 31.63416, 'lon': -7.99994}}], 'centralContacts': [{'name': 'Nizar Amllah, M.D', 'role': 'CONTACT', 'email': 'nizaramllah@gmail.com', 'phone': '+212 613069684'}, {'name': 'Meryem Essafti, Assistant Professor', 'role': 'CONTACT', 'email': 'essafti.m@gmail.com', 'phone': '+212 662393700'}], 'overallOfficials': [{'name': 'Meryem Essafti, Assistant Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Mohammed VI Marrakech'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 3 months and ending 1 year after the publication of results', 'ipdSharing': 'YES', 'description': 'All data collected throughout the trial will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU Mohammed VI Marrakech', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Meryem Essafti', 'investigatorAffiliation': 'CHU Mohammed VI Marrakech'}}}}