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

Not Applicable

Completed

• Conditions: Obstetric Perineal Rupture
• Interventions: Device: Objective measurements of perineal tears with "Peri-Rule"; Other: Visual and digital assessment

• Registration Number: NCT01278979
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-17
• Study First Posted: 2011-01-19
• Primary Completion: 2012-06
• Study Completion: 2013-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assessment of perineal tears	Objective measurements of perineal tears with "Peri-Rule"	Consenting women sustaining perineal tear after child birth
Visual and digital assessment	Visual and digital assessment	Consenting women that sustained perineal tear after child birth.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Consistency between different midwife practitioners when the classify and evaluate perineal tears.	One and a half years	Two different midwife practitioners' assess the same perineal tear and fill out an assessment protocol independently.

Trial Locations

Locations (1)

Ostfold Hospital Trust; 🇳🇴 Fredrikstad, Ostfold, Norway