Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 3:59 AM
Study NCT ID:
NCT02198157
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Catheterization and Second Stage of Labor
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-20', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'post-partum hemorrhage', 'timeFrame': 'within the first 48 hours after delivery'}], 'primaryOutcomes': [{'measure': 'duration of second stage of labor', 'timeFrame': 'within the first 48 hours after delivery'}], 'secondaryOutcomes': [{'measure': 'chorioamnionitis', 'timeFrame': 'within the first 48 hours after delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['duration of second stage', 'urinary catheterization', 'epidural anaesthesia'], 'conditions': ['Labor, Second Stage']}, 'descriptionModule': {'briefSummary': '* Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta\n* The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes\n* Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.\n* Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage\n* Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.\n* Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.\n* This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women\n* Gestational age 24-42 weeks\n* epidural anaesthesia\n* Vertex presentation\n* Singleton\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02198157', 'acronym': 'cath2stage', 'briefTitle': 'Urinary Catheterization and Second Stage of Labor', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration', 'orgStudyIdInfo': {'id': '45-14-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intermittent urinary catheterization', 'description': 'nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization', 'interventionNames': ['Other: urinary catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous urinary catheter', 'description': 'nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization', 'interventionNames': ['Other: urinary catheterization']}], 'interventions': [{'name': 'urinary catheterization', 'type': 'OTHER', 'otherNames': ['continuous versus intermittent catheterization.'], 'description': 'nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.', 'armGroupLabels': ['continuous urinary catheter', 'intermittent urinary catheterization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Dep. OB/GYN, HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'raed salim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dep. OB/GYN, HaEmek Medical Center, Afula, Israel'}, {'name': 'abeer suleiman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. OB/GYN, HaEmek Medical Center, Afula, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raed Salim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Raed Salim', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}