Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 2:48 PM
Study NCT ID:
NCT05720650
Status:
WITHDRAWN
Last Update Posted:
2023-04-11
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
B Vitamin Deficiency and Pregnancy Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'maternal blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'plans changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gestational hypertension', 'timeFrame': 'seven days after delivery', 'description': 'Gestational hypertension is diagnosed when blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine).'}, {'measure': 'preeclampsia', 'timeFrame': 'seven days after delivery', 'description': 'Gestational hypertension is diagnosed when blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has positive proteinuria (excess protein in the urine).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['B vitamins', 'pregnancy complications'], 'conditions': ['Gestational Hypertension', 'Preeclampsia']}, 'descriptionModule': {'briefSummary': 'This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.', 'detailedDescription': "In clinical practice, women diagnosed with gestational hypertension or preeclampsia will be asked to participate this study to fill a questionnaire reporting their basic information. Meanwhile, women with matched age and gestation week and without any kinds of hypertensive disorders will also be invited for this study. Participants' blood samples will be analyzed for B vitamin levels at the end of the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women aged 18-45 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women aged 18-40 years old\n\nExclusion Criteria:\n\n* women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.\n* women with severe physical or mental diseases'}, 'identificationModule': {'nctId': 'NCT05720650', 'briefTitle': 'B Vitamin Deficiency and Pregnancy Complications', 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': 'B Vitamin Deficiency and Pregnancy Complications', 'orgStudyIdInfo': {'id': 'WestlakeU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case subjects diagnosed with gestational hypertension or preeclampsia', 'description': 'This is a restrospective observational study and there is no intervention.', 'interventionNames': ['Other: No intervention']}, {'label': 'Control subjects diagnosed without any hypertensive disorders', 'description': 'This is a restrospective observational study and there is no intervention.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Case subjects diagnosed with gestational hypertension or preeclampsia', 'Control subjects diagnosed without any hypertensive disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Hongjun SHI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westlake University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'collaborators': [{'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}