Trial Review

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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
Scientific title
Effect of vaginal antiseptic prior to Caesarean Section on the rate of Post-Caesarean complications: A blinded randomised controlled trial
Secondary ID [1] 301425 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
Nil Known
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
postpartum sepsis 317706 0
Condition category
Condition code
Reproductive Health and Childbirth 315784 315784 0 0
Childbirth and postnatal care
Infection 316473 316473 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 317737 0
Prevention
Comparator / control treatment


1)No prepping arm
Control group
Active

Outcomes
Primary outcome [1] 323993 0
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
Timepoint [1] 323993 0
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
Secondary outcome [1] 383518 0
• 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
Timepoint [1] 383518 0
fortnightly after caesarean until 28days postdischarge
Secondary outcome [2] 385241 0
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
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
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
Timepoint [3] 385242 0
fortnightly after caesarean until 28days postdischarge

Eligibility
Key inclusion criteria
Any patients undergoing for either emergency or elective CS that provided voluntary informed consent will be included in the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
15/03/2022
Actual
Date of last data collection
Anticipated
15/04/2022
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16825 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 30448 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 305863 0
Hospital
Name [1] 305863 0
Goulburn valley health
Country [1] 305863 0
Australia
Primary sponsor type
Hospital
Name
Goulburn valley health
Address
Goulburn Valley health
2/2-48Graham Street
Shepparton
VIC 3630
Country
Australia
Secondary sponsor category [1] 306313 0
None
Name [1] 306313 0
Address [1] 306313 0
Country [1] 306313 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306123 0
goulburn valley ethics committee
Ethics committee address [1] 306123 0
GV health Human Research ethics committee
Goulburn valleyhealth
2/2-48 Graham street
Shepparton
VIC 3630
Ethics committee country [1] 306123 0
Australia
Date submitted for ethics approval [1] 306123 0
27/05/2020
Approval date [1] 306123 0
Ethics approval number [1] 306123 0

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
Trial website
Not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102790 0
Dr Monika Trivedi
Address 102790 0
Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
Country 102790 0
Australia
Phone 102790 0
+610358322322
Fax 102790 0
Email 102790 0
drmonikatrivedi@gmail.com
Contact person for public queries
Name 102791 0
Dr Monika Trivedi
Address 102791 0
Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
Country 102791 0
Australia
Phone 102791 0
+610358322322
Fax 102791 0
Email 102791 0
monika.trivedi@gvhealth.org.au
Contact person for scientific queries
Name 102792 0
Dr Monika Trivedi
Address 102792 0
Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630
Country 102792 0
Australia
Phone 102792 0
+610358322322
Fax 102792 0
Email 102792 0
drmonikatrivedi@gmail.com

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?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  drmonikatrivedi@gmail.com 379933-(Uploaded-01-09-2020-11-49-47)-Study-related document.docx
Informed consent form  drmonikatrivedi@gmail.com 379933-(Uploaded-03-08-2020-11-46-40)-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
SourceTitleYear of PublicationDOI
EmbaseEffect of vaginal antiseptic prior to caesarean section on the rate of post-caesarean complications: a blinded randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-021-05857-7
N.B. These documents automatically identified may not have been verified by the study sponsor.