Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
Primary Purpose
Obstetric Perineal Rupture
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Objective measurements of perineal tears with "Peri-Rule"
Visual and digital assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstetric Perineal Rupture focused on measuring obstetric, perineal tear, perineal injury, diagnosis
Eligibility Criteria
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
Sites / Locations
- Ostfold Hospital Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Assessment of perineal tears
Visual and digital assessment
Arm Description
Consenting women sustaining perineal tear after child birth
Consenting women that sustained perineal tear after child birth.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01278979
First Posted
January 11, 2011
Last Updated
May 20, 2013
Sponsor
Ostfold Hospital Trust
Collaborators
Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT01278979
Brief Title
Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
Official Title
Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Göteborg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Perineal Rupture
Keywords
obstetric, perineal tear, perineal injury, diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessment of perineal tears
Arm Type
Active Comparator
Arm Description
Consenting women sustaining perineal tear after child birth
Arm Title
Visual and digital assessment
Arm Type
Other
Arm Description
Consenting women that sustained perineal tear after child birth.
Intervention Type
Device
Intervention Name(s)
Objective measurements of perineal tears with "Peri-Rule"
Other Intervention Name(s)
Peri-Rule
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Visual and digital assessment
Other Intervention Name(s)
Visual assessment, Digital assessment
Intervention Description
Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.
Primary Outcome Measure Information:
Title
To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears.
Description
Assessment of perineal tears using different two different assessment methods
Time Frame
One and a half years
Secondary Outcome Measure Information:
Title
Consistency between different midwife practitioners when the classify and evaluate perineal tears.
Description
Two different midwife practitioners' assess the same perineal tear and fill out an assessment protocol independently.
Time Frame
One and a half years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann IC Morris, Reg. Midwife
Organizational Affiliation
Ostfold HT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ostfold Hospital Trust
City
Fredrikstad
State/Province
Ostfold
ZIP/Postal Code
1603
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
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