Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 2:04 PM
Study NCT ID:
NCT04287933
Status:
UNKNOWN
Last Update Posted:
2020-02-27
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Drain in Decreasing Postoperative Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of women who will have complications', 'timeFrame': 'within 2 weeks', 'description': 'How many women who will have complications postoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'postoperative complications are common after cesarean section', 'detailedDescription': 'wound infection can occur after cesarean section'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women who will have complications after cesarean sectin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen undergoing cesarean section\n\nExclusion Criteria:\n\n* Women who deliver by normal vaginal delivery'}, 'identificationModule': {'nctId': 'NCT04287933', 'briefTitle': 'Role of Drain in Decreasing Postoperative Complications', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Role of Drain in Decreasing Postoperative Complications After Cesarean Section', 'orgStudyIdInfo': {'id': 'drain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drain', 'interventionNames': ['Device: Drain insertion']}, {'type': 'NO_INTERVENTION', 'label': 'No drain'}], 'interventions': [{'name': 'Drain insertion', 'type': 'DEVICE', 'description': 'insertion of a drain', 'armGroupLabels': ['Drain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mahmoud Alalfy, PhD', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '01002611058'}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Algezeera hospitaland National Research Centre ,Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}