We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01278979
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : May 21, 2013
Göteborg University
Information provided by (Responsible Party):
Ann Morris, Ostfold Hospital Trust

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

Condition or disease Intervention/treatment
Obstetric Perineal Rupture Device: Objective measurements of perineal tears with "Peri-Rule" Other: Visual and 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.
Study Start Date : January 2011
Primary Completion Date : June 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278979

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

Responsible Party: Ann Morris, authorized midwife and master student, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01278979     History of Changes
Other Study ID Numbers: ann2010
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Ann Morris, Ostfold Hospital Trust:
perineal tear
perineal injury

Additional relevant MeSH terms:
Wounds and Injuries