Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 4:21 PM
Study NCT ID:
NCT05071534
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of the Robson Classification of Cesearn Section in Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-18', 'releaseDate': '2022-07-06'}], 'estimatedResultsFirstSubmitDate': '2022-07-06'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of cesearn sections in sohag university hospital', 'timeFrame': 'Within 6 months', 'description': 'Number of cesearn sections per year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Robson Classification System']}, 'descriptionModule': {'briefSummary': "Aim Of The Work find out the frequency and indications for CS in sohag university hospitals and to analyze them according to Robson' ten group classification. This would be helping in adopting suitable measures to reduce the CS rate and identifying various challenges in our setting.", 'detailedDescription': 'Cesarean Section Is A Surgical Procedure Used to Deliver A Baby Through Incisions In The Abdomen And Uterus . The incidence of Caesarean deliveries is increasing every day passing faraway beyond WHO recommended rate of 15% for all deliveries(1).\n\nThe rates of maternal morbidity and mortality are higher after CS compared to vaginal birth. CS is associated with an increased risk of abnormal placentation, uterine rupture, ectopic pregnancy, stillbirth, and preterm birth.\n\ntherefor Increase rate of unnecessary caesarean sections has been a growing concern in most parts of the world,Worldwide Caesarean section rates have risen from around 7% in 1990 to 21% in 2021 and are projected to continue over current decade if this trend continuees,by 2030 the highest rates are likely to be in Eastern Asia(63),Latin America and the Caribbean (54),Western Asia (50), Northen Africa (48),Southern Europe (47) and Australia and New Zealand(45) . According to the latest survey , one in five women in the world now deliver by caesarean section .Egypt has the highest rate of Caesarean section of 54 % in the Eastern Mediterranean Region , with no furthermore improvement to maternal and child mortality rates(2).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women more than 28wks who will be admitted for labour in sohag university hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women more than 28 wks who will be admitted for labour\n\nExclusion Criteria:\n\n* pregnant women less than 28wks\n* pregnant women presented with rupture uterus'}, 'identificationModule': {'nctId': 'NCT05071534', 'briefTitle': 'Implementation of the Robson Classification of Cesearn Section in Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Implementation of the Robson Classification of the Cesearn Section in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-21-09-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sahar Abdelfatah', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-06', 'type': 'RELEASE'}, {'date': '2023-05-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sahar Abdelfatah, Principal investigator, Sohag University'}}}}