Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT06242756
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014546', 'term': 'Urinary Catheterization'}], 'ancestors': [{'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-23', 'size': 189635, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-21T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time at readiness for discharge post-surgery', 'timeFrame': 'Prior to discharge, average of 2 days postpartum', 'description': 'Time at readiness for discharge post-surgery will be collected via a form that will be distributed to the postpartum nursing team.'}, {'measure': 'Time to ambulation', 'timeFrame': 'Prior to discharge, an average of 2 days postpartum', 'description': 'Time to ambulation will be collected via a form that will be distributed to the postpartum nursing team.'}], 'secondaryOutcomes': [{'measure': 'Incidence of urinary retention', 'timeFrame': 'Prior to discharge, an average of 2 days postpartum', 'description': "Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course"}, {'measure': 'Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum', 'timeFrame': 'first 4 weeks postpartum', 'description': 'Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum'}, {'measure': 'Incidence of bladder injury in surgery', 'timeFrame': 'During surgery', 'description': 'Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.'}, {'measure': 'Operating time', 'timeFrame': 'During surgery', 'description': 'Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.'}, {'measure': 'Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)', 'timeFrame': 'Prior to discharge, an average of 2 days postpartum', 'description': 'Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'bladder catheterization', 'foley'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on hospitalization time (readiness to discharge), time to ambulation, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.', 'detailedDescription': 'This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.\n\nExclusion criteria:\n\n\\- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease'}, 'identificationModule': {'nctId': 'NCT06242756', 'briefTitle': 'Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery', 'orgStudyIdInfo': {'id': 'REB24-0044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bladder catheterization', 'description': 'Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section.', 'interventionNames': ['Procedure: Bladder catheterization']}, {'type': 'NO_INTERVENTION', 'label': 'Non-use of bladder catheterization', 'description': 'Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter.'}], 'interventions': [{'name': 'Bladder catheterization', 'type': 'PROCEDURE', 'description': 'Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section.', 'armGroupLabels': ['Bladder catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephen Wood, MD', 'role': 'CONTACT', 'email': 'stephen.wood@albertahealthservices.ca', 'phone': '403-944-1438'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Stephen L. Wood, MD, MSc', 'role': 'CONTACT', 'email': 'stephen.wood@albertahealthservices.ca', 'phone': '403-944-1438'}], 'overallOfficials': [{'name': 'Stephen L. Wood, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}