Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000285853
Ethics application status
Approved
Date submitted
1/03/2012
Date registered
12/03/2012
Date last updated
17/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, randomised study Comparing cUrved versus straighT scissors to reduce episiotomy extension
– The CUT Trial
Scientific title
Among women requiring an episiotomy, does cutting with curved scissors versus straight scissors affect the incidence of third and fourth degree tears
Secondary ID [1] 280067 0
Nil
Universal Trial Number (UTN)
U1111-1128-7894
Trial acronym
The CUT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Birth injury 285975 0
Pain 285976 0
Condition category
Condition code
Reproductive Health and Childbirth 286165 286165 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Curved scissors to cut a single mediolateral episiotomy at the time of birth.
Intervention code [1] 284388 0
Treatment: Surgery
Intervention code [2] 284426 0
Prevention
Intervention code [3] 284434 0
Treatment: Devices
Comparator / control treatment
Straight scissors to cut a single mediolateral episiotomy at the time of birth.
Control group
Active

Outcomes
Primary outcome [1] 286634 0
A reduction in third or fourth degree perineal tears.

Third or Fourth degree tear defined as:

Third degree:
Injury to perineum involving the anal sphincter complex
3a: Less than 50% of external anal sphincter thickness torn
3b: More than 50% of external anal sphincter thickness torn
3c: Both internal and external anal sphincter torn

Fourth degree:
Injury to perineum involving the anal sphincter complex (external and internal anal sphincter) and anal epithelium (i.e. involving anal epithelium and / or rectal mucosa)
Timepoint [1] 286634 0
Following delivery
Secondary outcome [1] 296334 0
Pain: The VAS will be used to measure perception of pain. The VAS is an ungraded 100mm long horizontal straight line with the endpoints no pain to the left (0) and worst pain imaginable to the right
Timepoint [1] 296334 0
Pain will be assessed at one point between 12-24 hours post delivery
Secondary outcome [2] 296335 0
Infection: For surgical site surveillance, the clinician adheres to criteria defined by the National Nosocomaial Infection Surveillance System
Timepoint [2] 296335 0
Up to 3 weeks post delivery:
Secondary outcome [3] 296336 0
Dehiscence: A follow up phone call made by the Researcher to each participant 3 weeks following birth and data collected from chart audit relating to perineal outcome.
Timepoint [3] 296336 0
Up to 3 weeks post delivery
Secondary outcome [4] 296337 0
Length of hospital stay
Timepoint [4] 296337 0
At hospital discharge

Eligibility
Key inclusion criteria
1. Signed consent
2. Primipara
3. >36+6 weeks gestation
4. Vaginal birth
5. Mediolateral episiotomy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Women experiencing pregnancy loss
2. Multiple pregnancy
3. Water birth
4. Multiparity
5. Previous perineal surgery
6. Children under the age of 18 years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
patients will be allocated to their group using sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
16/04/2013
Date of last participant enrolment
Anticipated
21/06/2013
Actual
12/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 936 0
Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors
Funding source category [1] 287151 0
Charities/Societies/Foundations
Name [1] 287151 0
RBWH Foundation
Country [1] 287151 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 283698 0
None
Name [1] 283698 0
Address [1] 283698 0
Country [1] 283698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286807 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 286807 0
Level 7, Block 7
Royal Brisbane and Women's Hospital
Butterfield St
Herston
QLD 4029
Ethics committee country [1] 286807 0
Australia
Date submitted for ethics approval [1] 286807 0
12/02/2012
Approval date [1] 286807 0
01/03/2012
Ethics approval number [1] 286807 0
HREC/12/QRBW/36

Summary
Brief summary
Third and 4th degree tears occur during childbirth when an episiotomy (a cut made to enlarge the birth canal) extends to the anal sphincter. At the research hospital, higher than average rates of 3rd and 4th degree tears have been observed among women having their first child. Episiotomies are generally cut on an angle, away from the anus but studies suggest that the angle is often less than the recommended 45 degrees. One strategy to ensure a 45 degree angle and to potentially decrease 3rd and 4th degree tears may be to use curved scissors that naturally take the incision away from the anus. The proposed study will test this assumption by comparing straight and curved scissors to cut an episiotomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33860 0
Mrs Angela Swift
Address 33860 0
Birth Suite
RBWH
Butterfield St
Herston
QLd 4029
Country 33860 0
Australia
Phone 33860 0
+61 7 3647 3933
Fax 33860 0
Email 33860 0
[email protected]
Contact person for public queries
Name 17107 0
Mrs Angela Swift
Address 17107 0
Birth Suite
Royal Brisbane and Women's Hospital
Butterfield st
Herston QLD 4029
Country 17107 0
Australia
Phone 17107 0
+61 7 3636 4244
Fax 17107 0
+61 7 3636 2123
Email 17107 0
[email protected]
Contact person for scientific queries
Name 8035 0
Mrs Angela Swift
Address 8035 0
Birth Suite
Royal Brisbane and Women's Hospital
Butterfield st
Herston QLD 4029
Country 8035 0
Australia
Phone 8035 0
+61 7 3636 4244
Fax 8035 0
+61 7 3636 2123
Email 8035 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.