Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?

Ostfold Hospital Trust

Status: Completed

Conditions: Obstetric Perineal Rupture

Treatments: Device: Objective measurements of perineal tears with "Peri-Rule"; Other: Visual and digital assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01278979

ann2010

Details and patient eligibility

About

This study aims to compare different midwife practitioners assessments of perineal tears.

Full description

Perineal injuries are one of the traumas most frequently suffered by women during delivery.Countries report wide variations in trauma rates, and within countries further variations exists among institutions and also among professional groups of caregivers.Visual and digital examination of the wound has been and is the most common way to assess and classify a perineal tear. However resent studies indicate that many tears diagnosed with this method are misclassified.The suggested reasons for this, apart from the fact that bleeding and tissue oedema make the diagnose difficult, is that many healthcare providers have too little training in perineal assessment and basic anatomy.

In this prospective randomised trial consenting women will be randomised in to the common visual and digital assessment of the perineal tear by to different midwives, blinded to each others assessment or visual and digital assessment and measuring of the tear with a small soft ruler, Peri-Rule also by two different midwives.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Spontaneous vaginal birth
• Women over 18 years of age
• Healthy Child
• Written consent signed by participant
• Spontaneous tear in perineum that involves the perineal skin

Exclusion criteria

• Bleeding from tears that demand suturing immediately.
• Bleeding that affected the general condition negatively
• Complex tears that branched out in two or more different directions
• Women delivered instrumentally forceps or ventouse
• Women delivered with Cesarian section
• Women who sustain episiotomy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Assessment of perineal tears

Active Comparator group

Description:

Consenting women sustaining perineal tear after child birth

Treatment:

Device: Objective measurements of perineal tears with "Peri-Rule"

Visual and digital assessment

Other group

Description:

Consenting women that sustained perineal tear after child birth.

Treatment:

Other: Visual and digital assessment