Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-29 @ 8:47 PM
Study NCT ID:
NCT04486456
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hb', 'timeFrame': 'Completed by observation，an average of 1 year', 'description': 'Proportion of patients with Hb\\<110g/L'}], 'secondaryOutcomes': [{'measure': 'SF', 'timeFrame': 'Completed by observation，an average of 1 year', 'description': 'Proportion of patients with SF\\<20μg/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron deficiency', 'Anemia during pregnancy'], 'conditions': ['Prevalence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the prevalence of anemia and iron deficiency in pregnancy through a multi-center, prospective follow-up study . To explore the influence factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and iron deficiency in pregnancy on maternal and fetal outcomes.', 'detailedDescription': '1. To understand the epidemiological characteristics of anemia and iron deficiency in pregnancy and describe the epidemiological situation of anemia and iron deficiency.\n2. To explore the influence factors of anemia and iron deficiency in pregnancy.\n3. To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy outcome of mothers and infants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnancy patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular prenatal check-ups were conducted in the hospitals participating in the study, and pregnant women who planned to give birth in hospital were established a maternity health manual\n* 18 years and older\n* Patients have to agree to participate by signing a consent\n\nExclusion Criteria:\n\n* have severe chronic diseases with Pre-pregnancy\n* Suffer from severe mental illness'}, 'identificationModule': {'nctId': 'NCT04486456', 'briefTitle': 'Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China', 'orgStudyIdInfo': {'id': 'ERIC STUDY'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Song X Zhang', 'role': 'CONTACT', 'email': '1033341681@qq.com', 'phone': '13901024399'}], 'overallOfficials': [{'name': 'Xia H Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Peking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Huixia Yang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}