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Completed

NCT Number: NCT01278979

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

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

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Key information

Conditions

Obstetric Perineal Rupture Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust

Fredrikstad, Østfold fylke, 1603, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Objective measurements of perineal tears with "Peri-Rule"

Device

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

Visual and digital assessment

Other

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

Other names: Visual assessment, Digital assessment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 19, 2011
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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