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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02827058 |
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Date of registration:
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06/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Influence of Needle Diameter on Post Dural Puncture Headache
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Scientific title:
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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 |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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65 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02827058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Jan Sverre Vamnes, md |
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Address:
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Telephone:
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Email:
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Affiliation:
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Østvold Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- healthy
- pregnant
- spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade
2-4)
- informed consent
Exclusion Criteria:
- chronic headache
- (attempt to) epidural anesthesia
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Post-Dural Puncture Headache
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Intervention(s)
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Device: G25 pencil point needle
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Device: G27 pencil point needle
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Primary Outcome(s)
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number of attempts until successful injection
[Time Frame: 0 (injection time before delivery)]
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Secondary Outcome(s)
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incidence of post dural puncture headache
[Time Frame: 48 hrs]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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