A Device Designed to Protect the Perineum During Labor
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Study of Perineal Protection Device|
- Grade I and II rupture during delivery [ Time Frame: time at the delivery department (up to 12 months) ] [ Designated as safety issue: Yes ]Number and extension of perineal tears during delivery
|Study Start Date:||November 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Perineal device used
Use of the perineal device during delivery
Device: Perineal protection device
Use of the device during delivery and inspection afterwards to see the tears.
Other Name: Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
No Intervention: No intervention
Controls, delivered as normal
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
|Helsingborg, Sweden, 25187|
|Principal Investigator:||Knut Haadem, MD, PhD||Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden|