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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COMPLETED
PHASE2
1200 participants
INTERVENTIONAL
2010-11-30
2011-11-30
Brief Summary
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To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
Design:
A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.
Main outcome measures:
The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.
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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 used
Use of the perineal device during delivery
Perineal protection device
Use of the device during delivery and inspection afterwards to see the tears.
No intervention
Controls, delivered as normal
No interventions assigned to this group
Interventions
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Perineal protection device
Use of the device during delivery and inspection afterwards to see the tears.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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Lund University Hospital
OTHER
Skane University Hospital
OTHER
Helsingborgs Hospital
OTHER
Responsible Party
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Knut Haadem
Principal investigator
Principal Investigators
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Knut Haadem, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden
Locations
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Knut Haadem
Helsingborg, Helsingborg, Sweden
Countries
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References
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Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30.
Other Identifiers
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148/2008
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KH-HBG-12
Identifier Type: -
Identifier Source: org_study_id
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