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

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

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

Study Overview

• Status: Completed
• Conditions: Obstetric Perineal Rupture
• Intervention / Treatment: Device: Objective measurements of perineal tears with "Peri-Rule"; Other: Visual and digital assessment

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Ostfold
    • Fredrikstad, Ostfold, Norway, 1603
      • Ostfold Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Assessment of perineal tears; Consenting women sustaining perineal tear after child birth	Device: Objective measurements of perineal tears with "Peri-Rule"; 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.; Other Names: Peri-Rule
Other: Visual and digital assessment; Consenting women that sustained perineal tear after child birth.	Other: Visual and digital assessment; Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.; Other Names: Visual assessment; Digital assessment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Ann IC Morris, Reg. Midwife, Ostfold HT

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 17, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: diagnosis; obstetric; perineal tear; perineal injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: ann2010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No