Trial Review

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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001154796p
Ethics application status
Submitted, not yet approved
Date submitted
17/08/2022
Date registered
23/08/2022
Date last updated
23/08/2022
Date data sharing statement initially provided
23/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to compare stool softeners versus osmotic laxatives following obstetric anal sphincter injury examining defecation outcomes, wound dehicence and risk of anal incontinence
Scientific title
A pilot study to compare stool softeners versus osmotic laxatives following obstetric anal sphincter injury examining defecation outcomes, wound dehicence and risk of anal incontinence
Secondary ID [1] 307802 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OASIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstetric anal sphincter injury 327386 0
Anal incontinence 327387 0
Wound healing 327388 0
Condition category
Condition code
Oral and Gastrointestinal 324545 324545 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
osmotic laxatives (lactulose) 15mg twice daily oral liquid.
Medication for 2 weeks, commencing day 1 post birth on postnatal ward and continue for 2 weeks post discharge to home.
Medication compliance assessed in hospital by medication chart completion and on discharged check by continence team 2 week phone call.
Bulking fibre (Ipsaghula) is routinely given to postnatal women and will continue to be prescribed at one sachet twice daily for 2 weeks. Each sachet obtains 3.5mg of ispaghula husks mixed in one glass of water (150ml) and taken orally twice daily. Medication commenced and assessed for compliance as above for 2 week timeframe.
Intervention code [1] 324264 0
Treatment: Drugs
Comparator / control treatment
Stool softener (Coloxyl) 200mg daily oral tablets
Medication for 2 weeks, commencing day 1 post birth on postnatal ward and continue for 2 weeks post discharge to home.
Medication compliance assessed in hospital by medication chart completion and on discharged check by continence team 2 week phone call.
Bulking fibre (Ipsaghula) is routinely given to postnatal women and will continue to be prescribed at one sachet twice daily for 2 weeks. Each sachet obtains 3.5mg of ispaghula husks mixed in one glass of water (150ml) and taken orally twice daily.Medication commenced and assessed for compliance as above for 2 week timeframe
Control group
Active

Outcomes
Primary outcome [1] 332340 0
Ease of evacuation - A reporting tool will assess the ease of evacuation visual analogue score . Scale from zero means no concern to 10 major concerns
Timepoint [1] 332340 0
At 2 weeks post commencement of the laxative ease of evacuation will be measured.
After this timeframe when the medications are ceased ease of evacuation will be measured at 6 weeks and 12 weeks to compare evacuation
Secondary outcome [1] 413100 0
continence status of the bowel assessed using the St Marks fecal incontinence score, and Bowel screening tool for women (BSQ) will assess anal incontinence. The Cleveland Constipation score will be used to exclude constipation
Timepoint [1] 413100 0
Baseline bowel status assessed at day 1 by continence nurse team.
At 2 weeks post commencement of the laxative continence status for bowel will be measured.
After this timeframe when the medications are ceased and continence status will be measured at 6 weeks and 12 weeks to compare evacuation
Secondary outcome [2] 413101 0
wound dehiscence will be assessed using a dichotomous scale with free text comments
Timepoint [2] 413101 0
Base line data collected by continence nurse team day 1 post birth.
At 2 weeks post commencement of the laxative wound dehiscence for bowel will be measured.
After this timeframe when the medications are ceased and wound dehiscence will be measured at 6 weeks and 12 weeks to compare evacuation2 weeks
Secondary outcome [3] 413208 0
Quality of life will be assessed using SF -12
Timepoint [3] 413208 0
quality of life will be assessed at 12 week face to face appointment by the continence team.

Eligibility
Key inclusion criteria
All women sustaining an obstetric anal sphincter injury at the study site who can provide informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of anal incontinence
No obstetric anal sphincter injury
History of chronic constipation
History of colorectal disease such as inflammatory bowel disease or colorectal malignancy
Allergy to study medication

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)
Allocation Concealed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web based randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study , no formal sample size calculation
STATA SE for analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
15/01/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22999 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 38311 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 312072 0
Government body
Name [1] 312072 0
Division Surgical Specialities and Anaesthetics Northern Adelaide Local Health Network
Country [1] 312072 0
Australia
Primary sponsor type
Individual
Name
Dr Elizabeth Murphy
Address
Divisional Director
Division of Surgical Specialties and Anesthetics Northern Adelaide Local Health Network
Lyell McEwin Hospital
Haydwon Rd
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 313580 0
None
Name [1] 313580 0
Address [1] 313580 0
Country [1] 313580 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311480 0
CALHN ethics committee
Ethics committee address [1] 311480 0
Central Adelaide Local Health Network
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 311480 0
Australia
Date submitted for ethics approval [1] 311480 0
16/08/2022
Approval date [1] 311480 0
Ethics approval number [1] 311480 0

Summary
Brief summary
Following childbirth tears to the perineum (area between the vaginal and bowel) and vagina are common occurring in 80 to 90% of women. Tears to the anus (bottom muscle) known as 3rd or 4th degree tears and occur in 3.5% of women giving birth in Australia. To promote healing of these tears, medications are given to soften the stool (poo). Currently all women following childbirth who have sustained a tear to the bowel muscles (3rd or 4th degree tear) would have laxatives ordered. Several types of medications known as laxatives are prescribed however we do not know which one is the best.
If you choose to be involved in the research, you will be allocated one of two laxatives that are prescribed for women following birth. The research team contact you and ask you about how easy it was to open your bowels (Poo), if you had any bowel incontinence (accidental loss of poo, gas or need to rush to the toilet for a Poo) or any concerns with healing of the wound (stitches). Information from this research will help guide development of a larger trial in the future.
The research project aims to see how several types of laxatives affect
1. How easy or hard it was to use your bowels (Poo) after birth and until 3 months following the birth of your baby.
2. If you have accidental leakage of (Poo), called anal incontinence following birth until 3 months post birth.
3. Any concerns about healing of the stitches (3rd and 4th degree tear) following birth until 3 months post birth.
? The Continence Nursing team routinely provide follow up care to women following 3rd and 4th degree tears. As part of the research, and on discharge from hospital, you will only be required to provide verbal feedback to questions on three occasions, about how easy or difficult it was to use your bowels (do a poo) if you have accidental loss of poo (anal incontinence) and how the
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121246 0
Dr Julie Tucker
Address 121246 0
c/o Women's and Children Division,
Family Clinic, Lyell McEwin Hospital
Northern Adelaide Local Health Network
Haydwon Rd
Elizabeth Vales SA 5112
Country 121246 0
Australia
Phone 121246 0
+61 435347338
Fax 121246 0
Email 121246 0
julie.tucker@sa.gov.au
Contact person for public queries
Name 121247 0
Dr Julie Tucker
Address 121247 0
c/o Women's and Children Division,
Family Clinic, Lyell McEwin Hospital
Northern Adelaide Local Health Network
Haydwon Rd
Elizabeth Vales SA 5112
Country 121247 0
Australia
Phone 121247 0
+61 435347338
Fax 121247 0
Email 121247 0
julie.tucker@sa.gov.au
Contact person for scientific queries
Name 121248 0
Dr Elizabeth Murphy
Address 121248 0
Divisional Director Division Of Surgical Specialties and Anaesthetics
Northern Adelaide Local Health Network
Lyell Mc Ewin Hospital
Haydwon Rd
Elizabeth Vales SA 5112
Country 121248 0
Australia
Phone 121248 0
+61 881829000
Fax 121248 0
Email 121248 0
elizabeth.murphy@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.