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

Study Overview
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Brief Summary
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This study aims to compare different midwife practitioners assessments of perineal tears.

Detailed Description
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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.

Official Title
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Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.

Conditions
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Obstetric Perineal Rupture

Intervention / Treatment
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* Device: Objective measurements of perineal tears with Peri-Rule
* Other: Visual and digital assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assessment of perineal tears<br>Consenting women sustaining perineal tear after child birth | Device: Objective measurements of perineal tears with Peri-Rule<br>* Four measurements will be used in this study. Depth of tear, from the fourchette into the greatest depth of the perineal body. Length of tear, from the fourchette to the apex of the vaginal tear. Length of tear, from the fourchette along perineal skin towards the anus. Length of the perineal body, from the fourchette to outer margin of anus.<br>* Other names: Peri-Rule;|
| Other: Visual and digital assessment<br>Consenting women that sustained perineal tear after child birth. | Other: Visual and digital assessment<br>* Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.<br>* Other names: Digital assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears. | Assessment of perineal tears using different two different assessment methods | One and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency between different midwife practitioners when the classify and evaluate perineal tears. | Two different midwife practitioners' assess the same perineal tear and fill out an assessment protocol independently. | One and a half years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstetric, perineal tear, perineal injury, diagnosis