Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
|ClinicalTrials.gov Identifier: NCT01278979|
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : May 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Perineal Rupture||Device: Objective measurements of perineal tears with "Peri-Rule" Other: Visual and digital assessment||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||February 2013|
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.
Other Name: Peri-Rule
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.
- To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears. [ Time Frame: One and a half years ]Assessment of perineal tears using different two different assessment methods
- Consistency between different midwife practitioners when the classify and evaluate perineal tears. [ Time Frame: One and a half years ]Two different midwife practitioners' assess the same perineal tear and fill out an assessment protocol independently.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278979
|Ostfold Hospital Trust|
|Fredrikstad, Ostfold, Norway, 1603|
|Principal Investigator:||Ann IC Morris, Reg. Midwife||Ostfold HT|