ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Infection

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]

Prevention

Comparator / control treatment

1)No prepping arm

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

• 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]

fortnightly after caesarean until 28days postdischarge

Secondary outcome [2]

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]

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]

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]

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?

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)

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]

Goulburn Valley Health - Shepparton campus - Shepparton

Recruitment postcode(s) [1]

3630 - Shepparton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Goulburn valley health

Address [1]

2/2-48 Goulburn valley Health
Graham street
Shepparton
VIC 3630

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

goulburn valley ethics committee

Ethics committee address [1]

GV health Human Research ethics committee
Goulburn valleyhealth
2/2-48 Graham  street 
Shepparton
VIC 3630

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2020

Approval date [1]

Ethics approval number [1]

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

Dr Monika Trivedi

Address

Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630

Country

Australia

Phone

+610358322322

Fax

drmonikatrivedi@gmail.com

Contact person for public queries

Name

Monika Trivedi

Address

Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630

Country

Australia

Phone

+610358322322

Fax

monika.trivedi@gvhealth.org.au

Contact person for scientific queries

Name

Monika Trivedi

Address

Goulburn valley Health
2/2-48 Graham street
Shepparton
VIC 3630

Country

Australia

Phone

+610358322322

Fax

drmonikatrivedi@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8138	Study protocol			drmonikatrivedi@gmail.com		379933-(Uploaded-01-09-2020-11-49-47)-Study-related document.docx
8139	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

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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Documents added manually

Documents added automatically