Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT06259656
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Thai term pregnant women are recruited at labor room, after informed consent was done. Characteristic data (such as vaccination type and time) and Maternal Blood was collected then cord blood was collected after birth. All blood was sent to test Anti SARs CoV antibody level. Then all data and 80 test result will analyzed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level', 'timeFrame': '1 month', 'description': 'Test for correlation of level in maternal and cord blood'}], 'secondaryOutcomes': [{'measure': 'Analysed time effect from last vaccination and type.', 'timeFrame': '1 month', 'description': 'Test for time effect after last dose of vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti SARs-CoV', 'Pregnancy', 'Cordblood', 'Vaccine'], 'conditions': ['Covid-19']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.', 'detailedDescription': 'The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai term pregnant women\n* 18-45 year old\n* At least 1 covid vaccination received\n* admission at Vachira Phuket Hospital Labor Room\n\nExclusion Criteria:\n\n* Do not want to participate\n* Unstable or Emergency condition'}, 'identificationModule': {'nctId': 'NCT06259656', 'briefTitle': 'Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.', 'organization': {'class': 'OTHER', 'fullName': 'Vachira Phuket Hospital'}, 'officialTitle': 'Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.', 'orgStudyIdInfo': {'id': 'VPH REC 009/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Thai term pregnant woman who have at least One dose of Covid vaccination', 'description': 'Maternal and cord blood was collected to test COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)', 'interventionNames': ['Diagnostic Test: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)']}], 'interventions': [{'name': 'COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)', 'armGroupLabels': ['Thai term pregnant woman who have at least One dose of Covid vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83000', 'city': 'Phuket', 'country': 'Thailand', 'facility': 'Vachira Phuket Hospital', 'geoPoint': {'lat': 7.89059, 'lon': 98.3981}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vachira Phuket Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}