Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02827058
Status:
TERMINATED
Last Update Posted:
2020-04-24
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Needle Diameter on Post Dural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'due to difficulties recruiting patients and therefore too slow progress', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of attempts until successful injection', 'timeFrame': '0 (injection time before delivery)'}], 'secondaryOutcomes': [{'measure': 'incidence of post dural puncture headache', 'timeFrame': '48 hrs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delivery, obstetric', 'Analgesia, Epidural', 'Injections, Epidural', 'Needles', 'Cesarean Section'], 'conditions': ['Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* pregnant\n* spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)\n* informed consent\n\nExclusion Criteria:\n\n* chronic headache\n* (attempt to) epidural anesthesia'}, 'identificationModule': {'nctId': 'NCT02827058', 'briefTitle': 'The Influence of Needle Diameter on Post Dural Puncture Headache', 'organization': {'class': 'OTHER', 'fullName': 'Helse Nord-Trøndelag HF'}, 'officialTitle': 'The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial', 'orgStudyIdInfo': {'id': '2016/140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G25 pencil point needle', 'description': 'healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle', 'interventionNames': ['Device: G25 pencil point needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G27 pencil point needle', 'description': 'healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle', 'interventionNames': ['Device: G27 pencil point needle']}], 'interventions': [{'name': 'G25 pencil point needle', 'type': 'DEVICE', 'armGroupLabels': ['G25 pencil point needle']}, {'name': 'G27 pencil point needle', 'type': 'DEVICE', 'armGroupLabels': ['G27 pencil point needle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fredrikstad', 'country': 'Norway', 'facility': 'Østfold Hospital', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Fredrikstad', 'country': 'Norway', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Levanger', 'country': 'Norway', 'facility': 'Levanger Hospital', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}], 'overallOfficials': [{'name': 'Jan Sverre Vamnes, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Østvold Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Ostfold', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}