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

This study has been completed.
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Ann Morris, Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01278979
First received: January 11, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Obstetric Perineal Rupture
Device: Objective measurements of perineal tears with "Peri-Rule"
Other: Visual and digital assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.

Further study details as provided by Ostfold Hospital Trust:

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. [ Time Frame: One and a half years ] [ Designated as safety issue: No ]
    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. [ Time Frame: One and a half years ] [ Designated as safety issue: No ]
    Two different midwife practitioners' assess the same perineal tear and fill out an assessment protocol independently.


Enrollment: 400
Study Start Date: January 2011
Study Completion Date: February 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  1. Depth of tear, from the fourchette into the greatest depth of the perineal body.
  2. Length of tear, from the fourchette to the apex of the vaginal tear.
  3. Length of tear, from the fourchette along perineal skin towards the anus.
  4. Length of the perineal body, from the fourchette to outer margin of anus.
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.
Other Names:
  • Visual assessment
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278979

Locations
Norway
Ostfold Hospital Trust
Fredrikstad, Ostfold, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
Göteborg University
Investigators
Principal Investigator: Ann IC Morris, Reg. Midwife Ostfold HT
  More Information

No publications provided

Responsible Party: Ann Morris, authorized midwife and master student, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01278979     History of Changes
Other Study ID Numbers: ann2010
Study First Received: January 11, 2011
Last Updated: May 20, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Ostfold Hospital Trust:
obstetric
perineal tear
perineal injury
diagnosis

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014