The Effect of the Modified Perineal Protection Device During Delivery
NCT ID: NCT02013752
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Perineal device during delivery
Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand.
Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Standard care
Standard care at delivery: Manual support of the perineum
Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Interventions
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Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Breech delivery
* Not understanding written and oral information
18 Years
45 Years
FEMALE
No
Sponsors
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Knut Haadem
OTHER
Responsible Party
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Knut Haadem
M.D., PhD
Principal Investigators
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Knut Haadem, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
Locations
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Dept Obstetrics and Gynecology, Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONLY-HBG
Identifier Type: REGISTRY
Identifier Source: secondary_id
KH-HBG-13
Identifier Type: -
Identifier Source: org_study_id
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