Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-04-13 @ 8:41 PM
Study NCT ID:
NCT05305261
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071700', 'term': 'Cone-Rod Dystrophies'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Maternal and cord blood samples taken to measure the antibody levels for Covid-19 at delivery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19', 'timeFrame': '30 minutes after delivery', 'description': 'Quantification of Covid-19 antibody levels in maternal and cord blood samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'antibody', 'pregnancy'], 'conditions': ['Antibody', 'Vaccine', 'Maternal', 'Cord']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.', 'detailedDescription': 'Covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. The introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. Channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. The efficacy of vaccination for the pregnant lady has been established. However, fetus protection via transmission of the antibody during pregnancy is still uncertain. Therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All vaccinated pregnant women at term with or without a history of covid-19 infection admitted in labour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term pregnancies at 37 weeks or more\n* vaccinated 2 doses\n* in labour\n\nExclusion Criteria:\n\n* unvaccinated\n* preterm labour less than 37 weeks\n* multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT05305261', 'briefTitle': 'Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19', 'orgStudyIdInfo': {'id': 'FF-2021-362'}}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'W.Persekutuan', 'country': 'Malaysia', 'facility': 'UKM Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malaysia Automotive Robotics and Innovation of Technology Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rahana Abd Rahman', 'investigatorAffiliation': 'National University of Malaysia'}}}}