Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00959920
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2009-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002408', 'term': 'Catheters, Indwelling'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smassey@lumc.edu', 'phone': '708-354-9250', 'title': 'Dr. Sarita Massey', 'organization': 'Loyola University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The are not limitations or caveats to disclose.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Indwelling Foley Catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intermittent Straight Catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Delivery (by Any Route)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indwelling Foley Catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.'}, {'id': 'OG001', 'title': 'Intermittent Straight Catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.43', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '15.34'}, {'value': '11.23', 'groupId': 'OG001', 'lowerLimit': '7.15', 'upperLimit': '15.31'}]}]}], 'analyses': [{'pValue': '.42', 'groupIds': ['OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.8', 'groupDescription': 'The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'Time to delivery defined as IV placement to delivery of infant.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.'}, {'type': 'SECONDARY', 'title': 'Difference in Cost Between the Two Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indwelling Foley Catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.\n\nIndwelling catheter: Indwelling bladder catheter will remain in place until time of delivery.'}, {'id': 'OG001', 'title': 'Intermittent Straight Catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.\n\nIntermittent straight catheterization: intermittent straight catheterization will be performed on an as needed basis until time of delivery.'}], 'timeFrame': 'End of study.', 'description': 'Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.', 'reportingStatus': 'POSTED', 'populationDescription': 'No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indwelling Foley Catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.'}, {'id': 'FG001', 'title': 'Intermittent Straight Catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled 7/09-11/09 from the obstetric units of the Loyola University Health System hospitals. Subjects included adult women with a singleton pregnancy who presented to the Labor \\& Deliver in active labor or for induction, were anticipated to have an normal spontaneous vaginal delivery (NSVD), and had an epidural.', 'preAssignmentDetails': 'Every patient was assigned to a group immediately following enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indwelling Foley Catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.'}, {'id': 'BG001', 'title': 'Intermittent Straight Catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '6', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '6', 'groupId': 'BG001'}, {'value': '28.14', 'spread': '6.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2009-08-14', 'resultsFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-24', 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Delivery (by Any Route)', 'timeFrame': '1 day', 'description': 'Time to delivery defined as IV placement to delivery of infant.'}], 'secondaryOutcomes': [{'measure': 'Difference in Cost Between the Two Interventions', 'timeFrame': 'End of study.', 'description': 'Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Indwelling bladder catheter', 'Intermittent straight catheterization', 'Labor and Delivery', 'Time to delivery during labor'], 'conditions': ['Labor']}, 'referencesModule': {'references': [{'pmid': '22540248', 'type': 'DERIVED', 'citation': 'Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.', 'detailedDescription': 'Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.\n\nThe goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission\n\nExclusion Criteria:\n\n* Women who are undergoing a scheduled cesarean delivery\n* Women with a contraindication to either of the 2 study interventions\n* Multi-fetal gestations\n* Current or planned tocolysis\n* Women who are on magnesium prophylaxis'}, 'identificationModule': {'nctId': 'NCT00959920', 'acronym': 'SOFT', 'briefTitle': 'Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Study of Obstetric Foley Therapy (SOFT Trial)', 'orgStudyIdInfo': {'id': '201539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Indwelling foley catheter', 'description': 'Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.', 'interventionNames': ['Procedure: Indwelling catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent straight catheterization', 'description': 'Intermittent straight catheterization will be performed as needed during labor.', 'interventionNames': ['Procedure: Intermittent straight catheterization']}], 'interventions': [{'name': 'Indwelling catheter', 'type': 'PROCEDURE', 'description': 'Indwelling bladder catheter will remain in place until time of delivery.', 'armGroupLabels': ['Indwelling foley catheter']}, {'name': 'Intermittent straight catheterization', 'type': 'PROCEDURE', 'description': 'intermittent straight catheterization will be performed on an as needed basis until time of delivery.', 'armGroupLabels': ['Intermittent straight catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Health System', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'overallOfficials': [{'name': 'Sarita Massey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}