Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-04 @ 11:06 PM
Study NCT ID:
NCT06557694
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy related complications', 'timeFrame': 'For one month', 'description': 'Pregnancy related complications as preterm birth, preeclampsia, intrauterine fetal demise (IUFD), increased cesarean section rate, postpartum hemorrhagic gastroenteritis (HGE) were collected'}], 'secondaryOutcomes': [{'measure': 'Intensive care unit admission rate', 'timeFrame': 'For one month', 'description': 'Intensive care unit admission rate was collected.'}, {'measure': 'Use of mechanical ventilation', 'timeFrame': 'For one year', 'description': 'Use of mechanical ventilation was collected.'}, {'measure': 'Incidence of death', 'timeFrame': 'For one month', 'description': 'Incidence of death was collected.'}, {'measure': 'Apgar score', 'timeFrame': 'For 5 minutes post-intervention', 'description': 'Apgar score is a quick test performed on a baby at 1 and 5 minutes after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Infection', 'Obstetric Complication', 'Maternal Outcomes']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.', 'detailedDescription': 'During the SARS-CoV-2 pandemic, pregnant women were reported to have a higher susceptibility to COVID-19 infection. Pregnant women who tested positive for SARS-CoV-2 are at higher risk of a severe form of COVID-19, associated with higher rates of intensive care unit (ICU) admission and increased needs for respiratory support, compared to the age-matched non-pregnant population.\n\nWomen infected during pregnancy also have an increased risk of adverse pregnancy outcomes including preterm-birth, with a significant proportion secondary to iatrogenic preterm birth due to maternal illness. Infection with SARS-CoV-2 during pregnancy has also been reported to be associated with a higher risk of stillbirth directly or indirectly caused by the virus.\n\nInfected pregnant patients tended to present asymptomatically with pre-Delta and Omicron variants, and symptomatically with Delta variant. A previous systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID-19, but they were at risk of severe COVID-19 compared with those who were not pregnant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study was carried out on 260 pregnant women with COVID-19 infection who presented in Tanta University Hospitals in the period from January 2021 to December 2022 with approval from the institutional ethical committee.', 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 40 years.\n* Pregnant women with COVID-19 infection diagnosed either by PCR or rapid test.\n\nExclusion Criteria:\n\n• Patients vaccinated for COVID-19 before or during the current pregnancy.'}, 'identificationModule': {'nctId': 'NCT06557694', 'briefTitle': 'Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes', 'orgStudyIdInfo': {'id': '36264PR750/7/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Data collection', 'description': 'Data collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization Pregnancy outcomes included mode of delivery, gestational age at delivery, pre-eclampsia, and postpartum hemorrhage (defined as an estimated blood loss of 1,000 mL or greater).', 'armGroupLabels': ['Data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mai Nabil Ageez', 'investigatorAffiliation': 'Tanta University'}}}}