Study of Perineal Protection Device
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Perineal Tear
- Sponsor
- Helsingborgs Hospital
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Grade I and II rupture during delivery
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Knut Haadem
Principal investigator
Helsingborgs Hospital
Eligibility Criteria
Inclusion Criteria
- •Vaginal delivery
Exclusion Criteria
- •Age below 18 years and no understanding of written and oral information.
Outcomes
Primary Outcomes
Grade I and II rupture during delivery
Time Frame: time at the delivery department (up to 12 months)
Number and extension of perineal tears during delivery