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Trial registered on ANZCTR
Registration number
ACTRN12620000971932p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2020
Date registered
28/09/2020
Date last updated
28/09/2020
Date data sharing statement initially provided
28/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of vaginal antiseptic prior to Caesarean Section on the rate of Post-Caesarean complications: A blinded randomised controlled trial
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Scientific title
Effect of vaginal antiseptic prior to Caesarean Section on the rate of Post-Caesarean complications: A blinded randomised controlled trial
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Secondary ID [1]
301425
0
Nil Known
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Universal Trial Number (UTN)
Nil Known
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Trial acronym
Nil Known
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Linked study record
Not applicable
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Health condition
Health condition(s) or problem(s) studied:
postpartum sepsis
317706
0
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Condition category
Condition code
Reproductive Health and Childbirth
315784
315784
0
0
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Childbirth and postnatal care
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Infection
316473
316473
0
0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients that will be undergoing for elective or emergency CS are randomised either to
Arm1-1% povidone iodine
Arm 2- chlorohexidine
Arm 3 no vaginal irrigation group.
Single vaginal Prepp will be done after anaesthesia is given, just prior to commencing Caesarean section,
could be done by Midwife or obstetrician present
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Intervention code [1]
317737
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Prevention
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Comparator / control treatment
1)No prepping arm
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Control group
Active
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Outcomes
Primary outcome [1]
323993
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Endometritis: defined as core temperature measured >38ºc with uterine tenderness and/or foul smelling vaginal discharge
1)calling the patient 2 weekly postpartum until 28 days post discharge
2)Medical records during admission/after discharge
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Assessment method [1]
323993
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Timepoint [1]
323993
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Telephonic follow up every fortnight after caesarean until 28 days post-discharge from hospital,
and
follow up during hospital presentation or admission until 28 days postdischarge
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Secondary outcome [1]
383518
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• Post-operative fever: defined as core temperature >38 ºc at any point until 7 days of post Caesarean section
The data will be collected;
1)Initially from pt at booking
2)Medical records
3)from telephonic review every fortnight till 28days post procedure
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Assessment method [1]
383518
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Timepoint [1]
383518
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fortnightly after caesarean until 28days postdischarge
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Secondary outcome [2]
385241
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Wound infection: defined as itch, redness, pain, swelling and collection of purulent discharge at the surgical incision site within 7days of CS
The data will be collected;
1)Initially from pt at booking
2)Medical records
3)from telephonic review every fortnight till 28days post procedure
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Assessment method [2]
385241
0
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Timepoint [2]
385241
0
fortnightly after caesarean until 28days postdischarge
pt goes home on Day 4-5 post Caesarean section
wound is checked routinely during the stay (daily checks)
If infection present - we will be informed by Midwife or doctors
If pt develops mild infection at home and they present to GP for treatment- we can find it out at 2 weekly check which is 4+ 7 from discharge - approx 2 weeks form day of CS
If significant infection- pt will present to hospital and we can review from the records
SO fortnightly check os more consistent and doable
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Secondary outcome [3]
385242
0
Readmission with infection: defined as representation of post CS patients to the hospital in 28 days of discharge with surgical site infection or related infective complications
The data will be collected;
1)Medical records
2)from telephonic review every fortnight till 28days post procedure
3)Directly from the patient during inpatient admission
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Assessment method [3]
385242
0
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Timepoint [3]
385242
0
fortnightly after caesarean until 28days postdischarge
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Eligibility
Key inclusion criteria
Any patients undergoing for either emergency or elective CS that provided voluntary informed consent will be included in the study.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Patients having signs of chorio, intrapartum pyrexia and other signs of infection will be excluded from the study.
• Patients who develop intrapartum pyrexia as a result of syntocinon drip, prolonged labour or obstructed labour and provided voluntary informed consent will be included in the study initially. Their placental swabs will be taken for microscopic examination, culture and sensitivity (m/cs). They will be excluded from the study only if their swab results are positive for m/cs.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After inclusion in the trial, each prospective CS patient will be assigned either into the intervention (1% povidone iodine or chlorohexidine) or control (no-irrigation) group by using a block randomization technique. A permuted block of six will be used to randomize the patients. A third party not related to the study will generate the permuted blocks and allocate the treatment in sealed opaque envelops.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After inclusion in the trial, each prospective CS patient will be assigned either into the intervention (1% povidone iodine or chlorohexidine) or control (no-irrigation) group by using a block randomization technique. A permuted block of six will be used to randomize the patients. A third party not related to the study will generate the permuted blocks and allocate the treatment in sealed opaque envelops.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We assume that the interventions will improve the rate of infection including post-operative infective complications (within 28 days of discharge from the hospital) by 50% compared to the control. Thus, for sample size estimation in this study we set P1 =8% (as per overall prevalence of post CS infection range 3-15%), P2 = 4%, significance level = 5% and the study power =80%.
Therefore, n = Za + Zß 2
ES
ES= P1-P2
vP1(1-P1)
n = 361
Here, Za = 1.96, Zß = 0.84, P1= 0.08, P2 =0.04, and P1-P2= 0.04.
Considering 5% drop out, the study will require recruiting approximately 375 participants for all the groups and 125 in each group over a period of sixteen (16) months to adequately test the assumption.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2020
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Actual
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Date of last participant enrolment
Anticipated
15/03/2022
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Actual
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Date of last data collection
Anticipated
15/04/2022
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Actual
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Sample size
Target
375
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
16825
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Goulburn Valley Health - Shepparton campus - Shepparton
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Recruitment postcode(s) [1]
30448
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3630 - Shepparton
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Funding & Sponsors
Funding source category [1]
305863
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Hospital
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Name [1]
305863
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Goulburn valley health
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Address [1]
305863
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2/2-48 Goulburn valley Health
Graham street
Shepparton
VIC 3630
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Country [1]
305863
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Australia
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Primary sponsor type
Hospital
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Name
Goulburn valley health
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Address
Goulburn Valley health
2/2-48Graham Street
Shepparton
VIC 3630
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Country
Australia
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Secondary sponsor category [1]
306313
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None
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Name [1]
306313
0
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Address [1]
306313
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Country [1]
306313
0
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
306123
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goulburn valley ethics committee
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Ethics committee address [1]
306123
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GV health Human Research ethics committee
Goulburn valleyhealth
2/2-48 Graham street
Shepparton
VIC 3630
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Ethics committee country [1]
306123
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Australia
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Date submitted for ethics approval [1]
306123
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27/05/2020
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Approval date [1]
306123
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Ethics approval number [1]
306123
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Summary
Brief summary
General Objective
To introduce uniform use of vaginal antiseptic wash immediately prior to Caesarean section and to determine the best antiseptic wash material in reducing post-operative infections or complications.
Specific Aims
1. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with either 1% povidone iodine or chlorohexidine or no toileting (control) during elective CS
2. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with 1% povidone iodine or chlorohexidine or no toileting (control) during emergency CS
3. To compare the rate of infections among the three groups that receiving either 1% povidone iodine or chlorohexidine or no toileting for vaginal irrigation prior to any kind of CS
4. To identify the best antiseptic wash and methods for vaginal irrigation prior to CS for developing a uniform guideline through locally generated evidence
5. To determine the factors that may influence the outcomes such as post-CS infections or related complications
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Trial website
Not applicable
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
102790
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Dr Monika Trivedi
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Address
102790
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Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
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Country
102790
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Australia
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Phone
102790
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+610358322322
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Fax
102790
0
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Email
102790
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[email protected]
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Contact person for public queries
Name
102791
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Dr Monika Trivedi
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Address
102791
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Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
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Country
102791
0
Australia
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Phone
102791
0
+610358322322
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Fax
102791
0
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Email
102791
0
[email protected]
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Contact person for scientific queries
Name
102792
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Dr Monika Trivedi
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Address
102792
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Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
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Country
102792
0
Australia
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Phone
102792
0
+610358322322
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Fax
102792
0
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Email
102792
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8138
Study protocol
[email protected]
379933-(Uploaded-01-09-2020-11-49-47)-Study-related document.docx
8139
Informed consent form
[email protected]
379933-(Uploaded-03-08-2020-11-46-40)-Study-related document.docx
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8138
Study protocol
[email protected]
379933-(Uploaded-21-12-2020-17-06-10)-Study-related document.docx
8139
Informed consent form
[email protected]
379933-(Uploaded-21-12-2020-17-07-25)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effect of vaginal antiseptic prior to caesarean section on the rate of post-caesarean complications: a blinded randomised controlled trial.
2022
https://dx.doi.org/10.1186/s13063-021-05857-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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