Obstetric Perineal RuptureNCT01278979
Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
A study testing Objective measurements of perineal tears with "Peri-Rule" and Visual and digital assessment in people with Obstetric Perineal Rupture, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
This study aims to compare different midwife practitioners assessments of perineal tears. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Perineal Rupture
- What is being tested?
- Objective measurements of perineal tears with "Peri-Rule" and Visual and digital assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.
This study aims to compare different midwife practitioners assessments of perineal tears.
Read the 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.
- Conditions
- Obstetric Perineal Rupture
- Being tested
- Objective measurements of perineal tears with "Peri-Rule", Visual and digital assessment
- Keywords
- obstetric, perineal tear, perineal injury, diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective measurements of perineal tears with "Peri-Rule"Device
Also called Peri-Rule
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.
Visual and digital assessmentOther
Also called Visual assessment, Digital assessment
Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.
| Study group | Role | What they receive |
|---|---|---|
| Assessment of perineal tears | Active comparator | Consenting women sustaining perineal tear after child birth Receives: Device: Objective measurements of perineal tears with "Peri-Rule" |
| Visual and digital assessment | Other | Consenting women that sustained perineal tear after child birth. Receives: Other: Visual and digital assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One and a half years
Secondary outcomes (1)
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.
Measured: One and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Perineal RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Ann Morris, Ostfold Hospital Trust
- Investigators
- Ann IC Morris, Reg. Midwife, Principal investigator, Ostfold HT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278979
- Sponsor's protocol ID
- ann2010
- Status last verified
- May 2013
- First submitted
- 11 Jan 2011
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.
- ClinicalTrials.gov ID
- NCT01278979
- Acronym / sponsor ID
- ann2010
- Conditions
- Obstetric Perineal Rupture
- Keywords
- obstetric, perineal tear, perineal injury, diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment of perineal tears | Active comparator | Device: Objective measurements of perineal tears with "Peri-Rule"Consenting women sustaining perineal tear after child birth |
| Visual and digital assessment | Other | Other: Visual and digital assessmentConsenting women that sustained perineal tear after child birth. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Objective measurements of perineal tears with "Peri-Rule"Also: Peri-RuleFour 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. | Device | Assessment of perineal tears |
| Visual and digital assessmentAlso: Visual assessment, Digital assessmentMidwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear. | Other | Visual and digital assessment |
Primary outcome
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
1 secondary outcome
Consistency between different midwife practitioners when the classify and evaluate perineal tears.
Time frame: One and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
Related trials for Obstetric Perineal Rupture
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Hands-on vs Hands-off Techniques in Perineal Protection
Perineal Trauma, Hands-on Technique
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Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
Sphincter (Anal); Perineal Rupture, Obstetric
Active, not recruiting
Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
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Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Episiotomy, Lacerations Perineal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann IC Morris, Reg. Midwife principal investigator
Ostfold HT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Objective measurements of perineal tears with "Peri-Rule" and Visual and digital assessment in people with Obstetric Perineal Rupture, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.