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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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4 December 2023 |
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Main ID: |
NCT02427854 |
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Date of registration:
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09/03/2015 |
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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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Palestinian Perineum and Birth Complication Study
PPS |
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Scientific title:
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Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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51041 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02427854 |
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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: Crossover Assignment. Primary purpose: Prevention. 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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Palestinian Territory, occupied
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Contacts
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Name:
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Åse Vikanes, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Name:
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Erik Fosse, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital, University of Oslo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all midwives and physicians working on labor ward in the participating hospitals.
- all women giving birth in the participating hospitals.
- both genders are included in the staff, and among the newborns
Exclusion Criteria:
- no exclusion criteria, the study aim is the education of the staff, and hospitals are
compared as units.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Complication of Labor and Delivery
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Intervention(s)
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Behavioral: Education by animated training video
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Procedure: Interactive hands-on bedside training
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Primary Outcome(s)
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Incidence of obstetric perineal injuries
[Time Frame: 24 months]
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Secondary Outcome(s)
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Occurrence of major delivery complications
[Time Frame: 24 months]
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Occurrence of perineal injuries after education of the staff on diagnostics and repair
[Time Frame: 24 months]
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Secondary ID(s)
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2014/1727
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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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