Perineal Tear
Conditions
Keywords
Delivery rupture, perineal protection device, reduce perineal tears
Brief summary
Objective: 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.
Detailed description
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
Interventions
DEVICEPerineal protection device
Use of the device during delivery and inspection afterwards to see the tears.
Sponsors
Lund University Hospital
Skane University Hospital
Helsingborgs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Vaginal delivery
Exclusion criteria
* Age below 18 years and no understanding of written and oral information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade I and II rupture during delivery | time at the delivery department (up to 12 months) | Number and extension of perineal tears during delivery |
Countries
Sweden
Outcome results
None listed