NCT01533467

A Device Designed to Protect the Perineum During Labor

Study of Perineal Protection Device

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Helsingborgs Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perineal Tear

Interventions

Type	Name	Description
DEVICE	Perineal protection device	Use of the device during delivery and inspection afterwards to see the tears.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2012-02-15
• Last updated: 2012-02-15

Locations

1 site across 1 country: Sweden