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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: |
NCT03071783 |
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Date of registration:
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01/03/2017 |
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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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Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
SVEA |
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Scientific title:
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Intra-operative Feed Back on Traction Force During Vacuum Extraction: a Randomized Control Study of Mid and Low Metal Cup Deliveries. |
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Date of first enrolment:
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April 1, 2016 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03071783 |
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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: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Magnus Westgren, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Medical or social reasons for vacuum extraction with a metal cup, gestational age
=37+0 weeks, singleton, cephalic
Exclusion Criteria:
- Multiple pregnancy, breech presentation, gestational age <37+0
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neonatal Convulsions
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Hypoxic Ischemic Encephalopathy
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Subgaleal Hematoma
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Intervention(s)
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Device: Vacuum extraction intelligent system
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Primary Outcome(s)
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Composite neonatal brain damage
[Time Frame: From start of extraction through 28 days after delivery (or until discharge from the hospital)]
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Secondary ID(s)
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KI-Clintec-SVEA
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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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