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

Obstetric Perineal Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278979
• Other study ID #: ann2010
• Status: Completed
• Phase: N/A
• First received: January 11, 2011
• Last updated: May 20, 2013
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstetric Perineal Rupture

Intervention

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

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad	Ostfold

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Göteborg University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No