Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-02 @ 5:19 PM
Study NCT ID:
NCT04869202
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Infection in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feto-maternal outcome', 'timeFrame': '1 year', 'description': 'fetal and maternal consequences of the infection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perinatology']}, 'descriptionModule': {'briefSummary': 'Prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by COVID-19 infection at various gestational ages. The follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.', 'detailedDescription': 'Pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or Ministry of health (MOH) laboratories will be followed up till delivery and discharge from the hospital.\n\nThey will be followed up for hospitalization, intensive care unit (ICU) admission, any complications (organ failure, DIC, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (IUGR), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, APGAR score at 1 and 5 minutes, neonatal infection with covid-19, neonatal ICU admission and breast feeding. Those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. There will be no exclusion of cases.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who contract COVID-19 virus infection during pregnancy', 'genderDescription': 'Pregnant women infected with COVID-19', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04869202', 'briefTitle': 'Covid-19 Infection in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Fetomaternal Outcomes of Pregnancies Complicated by COVID-19 Infection; Prospective Study in a Tertiary University Hospital', 'orgStudyIdInfo': {'id': 'Jordan University Hospital'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COVID-19 test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Naso-pharyngeal swab test'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Asma Basha', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Naser Al-Husban', 'investigatorAffiliation': 'University of Jordan'}}}}