A Device Designed to Protect the Perineum During Labor

Helsingborgs Hospital

Status and phase: Completed; Phase 2

Conditions: Perineal Tear

Treatments: Device: Perineal protection device

Study type: Interventional

Funder types: Other

Identifiers

NCT01533467

KH-HBG-12

148/2008 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vaginal delivery

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Perineal device used

Other group

Description:

Use of the perineal device during delivery

Treatment:

Device: Perineal protection device

No intervention

No Intervention group

Description:

Controls, delivered as normal