Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT04418557
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 and Obstetric Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000917', 'term': 'Antibody Formation'}], 'ancestors': [{'id': 'D007110', 'term': 'Immunity, Active'}, {'id': 'D056704', 'term': 'Adaptive Immunity'}, {'id': 'D007109', 'term': 'Immunity'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal secretion, cord blood, newborn throat swab, breastmilk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus', 'timeFrame': 'At time of delivery and 24 hours of life of the newborn', 'description': 'Innate/Adaptive cell function and immune response'}], 'primaryOutcomes': [{'measure': 'Presence of COVID-19 virus', 'timeFrame': 'At time of delivery', 'description': 'Viral presence in any of the collected specimens'}], 'secondaryOutcomes': [{'measure': 'Presence of antibodies to COVID-19 virus', 'timeFrame': 'At time of delivery and 24 hours of life of the newborn', 'description': 'Antibodies detected in any of the collected specimens'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '32215581', 'type': 'RESULT', 'citation': 'Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621.'}, {'pmid': '32151335', 'type': 'RESULT', 'citation': 'Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies exposed to a COVID-19 vaccine in Cuyahoga County.', 'detailedDescription': 'A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR; 10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19 positive were surveilled for vertical transmission and overall obstetric and early neonatal outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at the time of delivery, and breastmilk samples were collected after lactation commenced. There was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom have tested positively for COVID-19 after delivery from an infected mother. Most recently, antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery to a known positive mother. Therefore, vertical transmission has not been completely ruled out.\n\nAdditionally, infection at varying times of pregnancy has not been well delineated or correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need to continue surveying and documenting clinical findings in obstetric COVID-19 cases.\n\nThis study will follow pregnant women who are diagnosed during any point of their pregnancy with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.', 'genderDescription': 'must be pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 infection at any time of the pregnancy, or presumed case by symptoms and direct contact with a positive case\n* Pregnancy documented by ultrasound\n\nExclusion Criteria:\n\n* COVID-19 infection before or after pregnancy\n* Person under investigation, but not a presumed or known positive case'}, 'identificationModule': {'nctId': 'NCT04418557', 'acronym': 'COVIDOB', 'briefTitle': 'COVID-19 and Obstetric Transmission', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'COVID-19 and Obstetric Transmission', 'orgStudyIdInfo': {'id': '20200479'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women without COVID-19 Infection', 'description': 'Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative', 'interventionNames': ['Diagnostic Test: RT-PCR and antibody testing']}, {'label': 'Pregnant women with a history of COVID-19 infection', 'description': 'Women who are tested for COVID-19 at any point during their pregnancy, including at the time of admission for labor and delivery, and test positive', 'interventionNames': ['Diagnostic Test: RT-PCR and antibody testing']}, {'label': 'Pregnant women vaccinated for COVID-19', 'description': 'Women who are vaccinated against COVID-19 at any point during their pregnancy'}], 'interventions': [{'name': 'RT-PCR and antibody testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.', 'armGroupLabels': ['Pregnant women with a history of COVID-19 infection', 'Pregnant women without COVID-19 Infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cuyahoga County Board of Health', 'class': 'UNKNOWN'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rachel Pope', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}