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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-02-28

Brief Summary

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

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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.

Conditions

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Obstetric Perineal Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Assessment of perineal tears

Consenting women sustaining perineal tear after child birth

Group Type ACTIVE_COMPARATOR

Objective measurements of perineal tears with "Peri-Rule"

Intervention Type DEVICE

Four measurements will be used in this study.

1. Depth of tear, from the fourchette into the greatest depth of the perineal body.
2. Length of tear, from the fourchette to the apex of the vaginal tear.
3. Length of tear, from the fourchette along perineal skin towards the anus.
4. Length of the perineal body, from the fourchette to outer margin of anus.

Visual and digital assessment

Consenting women that sustained perineal tear after child birth.

Group Type OTHER

Visual and digital assessment

Intervention Type OTHER

Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.

Interventions

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Objective measurements of perineal tears with "Peri-Rule"

Four measurements will be used in this study.

1. Depth of tear, from the fourchette into the greatest depth of the perineal body.
2. Length of tear, from the fourchette to the apex of the vaginal tear.
3. Length of tear, from the fourchette along perineal skin towards the anus.
4. Length of the perineal body, from the fourchette to outer margin of anus.

Intervention Type DEVICE

Visual and digital assessment

Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.

Intervention Type OTHER

Other Intervention Names

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Peri-Rule Visual assessment Digital assessment

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes