Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000557437
Ethics application status
Date submitted
23/10/2007
Date registered
30/10/2007
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cooling for perineal pain relief after childbirth: randomised trial
Scientific title
Randomised controlled trial of two local cooling regimes for relieving pain from perineal trauma sustained during childbirth
Secondary ID [1] 288364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perineal pain 2495 0
Condition category
Condition code
Other 2592 2592 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Systematic use of Rest, Ice, Compression and Elevation (R.I.C.E.). This involves resting horizantally at times, instead of sitting up all the time; applying ice to the perineum for 20 minutes every 2-3 hours for 2-3 days; and wearing well fitting clothes (underwear).
Intervention code [1] 2223 0
Treatment: Other
Intervention code [2] 2244 0
Treatment: Other
Comparator / control treatment
Control = Standard care: ad hoc application of ice packs to the perineum. This is usually for 20 minutes every 2-3 hours for 2-3 days.
Control group
Active

Outcomes
Primary outcome [1] 3504 0
Women's self-reported perineal pain
Timepoint [1] 3504 0
Within 24 hours of giving birth
Secondary outcome [1] 5852 0
Pain
Timepoint [1] 5852 0
Within four to six hours;
within 24 hours (see primary);
between 24 and 72 hours;
between 3 and 5 days;
between 6 and 14 days;
six weeks and six months
AFTER GIVING BIRTH
Secondary outcome [2] 5853 0
Numerous other secondary outcomes related to perineal oedema, bruising, maternal exhausion, use of additional analgesia. Contact investigators for full list.
Timepoint [2] 5853 0
Within four to six hours; within 24 hours (see primary); between 24 and 72 hours; between 3 and 5 days; between 6 and 14 days; six weeks and six months AFTER GIVING BIRTH

Eligibility
Key inclusion criteria
Women having a vaginal birth who are willing and able to give informed consent and sustained perineal trauma (episiotomy / tear) or labial tears during childbirth
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to cooling treatments (eg peripheral neuropathy); Third or fourth degree perineal tear.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following informed consent and within the first two hours after giving birth, women will be randomly allocated to one of the two treatment groups using consecutively numbered sealed, opaque envolopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not otherwise involved in the study will generate the sequence using block randomisation (1:1 control:intervention), stratified for number of children born (vaginally), mode of birth and degree of perineal trauma.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Women and clinicians will be unblinded to treatment allocation. A researcher assessing perineal oedema and bruising will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2008
Actual
6/10/2008
Date of last participant enrolment
Anticipated
Actual
10/02/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
880
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 305 0
3053

Funding & Sponsors
Funding source category [1] 2744 0
Self funded/Unfunded
Name [1] 2744 0
Funding being sought from the Royal Women's Hospital Foundation and the Nurses' Board of Victoria.
Country [1] 2744 0
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
132 Grattan St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 2479 0
None
Name [1] 2479 0
Address [1] 2479 0
Country [1] 2479 0

Ethics approval
Ethics application status
Ethics committee name [1] 4662 0
Royal Women's Hospital HREC, Melbourne
Ethics committee address [1] 4662 0
Ethics committee country [1] 4662 0
Date submitted for ethics approval [1] 4662 0
31/10/2007
Approval date [1] 4662 0
27/06/2008
Ethics approval number [1] 4662 0
TBA

Summary
Brief summary
Perineal tears or cuts are common with childbirth and are often painful. Women are often advised to use ice packs to help relieve the pain, although there is very little evidence that this is effective. This trial will compare pain relief using two regimes of applying ice to the perineum. One group of women will have an ice pack applied to the perineum after giving birth, then replace it occasionally. The other group will have ice packs held firmly in place and be advised to rest and elevate the region. The results will enable a more evidence-based approach to care than is currently available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28140 0
Prof Christine
Address 28140 0
Dept Obstetrics and Gynaecology University of Melbourne / Royal Women's Hospital
Parkville VIC
Country 28140 0
Australia
Phone 28140 0
+61 3 83453700
Fax 28140 0
Email 28140 0
[email protected]
Contact person for public queries
Name 11297 0
Prof Christine East
Address 11297 0
Dept Obstetrics and Gynaecology University of Melbourne / Royal Women's Hospital
Parkville VIC
Country 11297 0
Australia
Phone 11297 0
+61 3 8345 3700
Fax 11297 0
Email 11297 0
[email protected]
Contact person for scientific queries
Name 2225 0
Prof Christine East
Address 2225 0
Country 2225 0
Australia
Phone 2225 0
+61 3 83453700
Fax 2225 0
Email 2225 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.