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.
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Use of the device during delivery and inspection afterwards to see the tears.
Knut Haadem
Helsingborg, Helsingborg, Sweden
Grade I and II rupture during delivery
Number and extension of perineal tears during delivery
Time frame: time at the delivery department (up to 12 months)
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