A Device Designed to Protect the Perineum During Labor

Phase 2

Completed

• Conditions: Perineal Tear
• Interventions: Device: Perineal protection device

• Registration Number: NCT01533467
• Lead Sponsor: Helsingborgs Hospital

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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-12
• Last Update Submitted: 2012-02-12
• Study First Posted: 2012-02-15
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• Vaginal delivery

Exclusion Criteria

• Age below 18 years and no understanding of written and oral information.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineal device used	Perineal protection device	Use of the perineal device during delivery

Primary Outcome Measures

Name	Time	Method
Grade I and II rupture during delivery	time at the delivery department (up to 12 months)	Number and extension of perineal tears during delivery

Trial Locations

Locations (1)

Knut Haadem; 🇸🇪 Helsingborg, Sweden