Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT02934906
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054098', 'term': 'Thrombocytopenia, Neonatal Alloimmune'}], 'ancestors': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55497}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The positive rate of anti-HPA antibody', 'timeFrame': 'Up to one and a half years after the study completed'}, {'measure': 'The morbidity of NAIT', 'timeFrame': 'Up to one and a half years after the study completed'}], 'secondaryOutcomes': [{'measure': 'Antigenic specificity of anti-HPA antibodies', 'timeFrame': 'Up to one and a half years after the study completed'}, {'measure': 'Association of anti-HPA antibody with HLA genotype as assessed by Chi-square test', 'timeFrame': 'Up to one and a half years after the study completed'}, {'measure': 'The relationship between the titer of anti-HPA antibody and clinical symptom severity in NAIT as assessed by Spearman Correlation assay', 'timeFrame': 'Up to one and a half years after the study completed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonatal Alloimmune Thrombocytopenia', 'pregnancy', 'human platelet allogantigen', 'asian', 'Chinese'], 'conditions': ['Neonatal Alloimmune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '28859622', 'type': 'DERIVED', 'citation': 'Chen L, Liu Z, Liu T, Ma X, Rao M, Wang Y, Sun B, Yin W, Zhang J, Yan B, Li X, Wang Q, Zhang L, Wen J, Liu F, Wang P, Wei Y, Huang Y, Wu J, Guo Y, Kang Y, Song X, Liu X, Zhang G, Xie T, Chen Y, Zeng X, Li Z. Neonatal alloimmune thrombocytopenia caused by anti-HPA antibodies in pregnant Chinese women: a study protocol for a multicentre, prospective cohort trial. BMC Pregnancy Childbirth. 2017 Aug 31;17(1):281. doi: 10.1186/s12884-017-1453-y.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an appropriate clinical screening procedure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Chinese women and their new borns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-28 weeks pregnant Chinese women\n* between Jan 1, 2017 and Dec 31, 2018\n\nExclusion Criteria:\n\n* Not willing to participate in this study\n* Plan to terminate pregnancy early'}, 'identificationModule': {'nctId': 'NCT02934906', 'briefTitle': 'Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women', 'orgStudyIdInfo': {'id': 'V2.0(20160720)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Pregnant women with anti-HPA antibody negative from the same hospital, the same race, and the same gravidity and parity, who are admitted at the same time.', 'interventionNames': ['Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion']}, {'label': 'Experimental Group', 'description': 'pregnant women with anti-HPA antibody positive', 'interventionNames': ['Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion']}], 'interventions': [{'name': 'Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion', 'type': 'PROCEDURE', 'description': 'Observational study.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Chen', 'role': 'CONTACT', 'email': 'chenli200401@163.com', 'phone': '0118615178936688'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Bengbu Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Jilin University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': "People's Hospital of Xinjiang Uygur Autonomous Region", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Southwest Medical University', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Qingdao University', 'class': 'OTHER'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'MCH Hospital of Yinchuan City', 'class': 'UNKNOWN'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Guangdong Pharmaceutical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief of Blood Transfusion Department', 'investigatorFullName': 'Zhongjun Li', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}