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Trial registered on ANZCTR


Registration number
ACTRN12622000336785
Ethics application status
Approved
Date submitted
21/11/2021
Date registered
23/02/2022
Date last updated
23/02/2022
Date data sharing statement initially provided
23/02/2022
Date results information initially provided
23/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vaginal cleansing in patients prior to emergency cesarean section and to see the effect on postoperative infections
Scientific title
Vaginal Cleansing Prior to Emergency Cesarean Section and Post-Operative Infectious Morbidity; Clinical Trial in a Low Resource Setting
Secondary ID [1] 305839 0
Nil known
Universal Trial Number (UTN)
U1111-1271-7927
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative wound infection 324377 0
postoperative fever 324378 0
postoperative endometritis 324379 0
emergency cesarean section 324867 0
infections 324870 0
infectious morbidity 324871 0
Condition category
Condition code
Infection 321862 321862 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 321863 321863 0 0
Childbirth and postnatal care
Surgery 321864 321864 0 0
Other surgery
Surgery 322306 322306 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaginal cleansing was performed with two gauzes using povidone iodine 10%, rotating each gauze sponge 360- degrees in the vagina for 30 seconds three times in “vaginal cleaning group” only by the obstetrician, 5 mins prior to incision.
The abdominal washing with povidone iodone 10% will be applied just prior to draping immediately after vaginal cleansing by the obstetrician.
Adherence to the intervention is monitored by the staff nurse in operation notes register
Intervention code [1] 322241 0
Treatment: Other
Intervention code [2] 322242 0
Prevention
Comparator / control treatment
The abdomen washing was done with povidone iodine 10% using 3 gauzes sponge in control groups in the operation theater.
Control group
Active

Outcomes
Primary outcome [1] 329619 0
postoperative endometritis by physical examination
Timepoint [1] 329619 0
six weeks postoperatively
Primary outcome [2] 329620 0
postoperative fever by using digital thermometer
Timepoint [2] 329620 0
six weeks postoperatively
Primary outcome [3] 329621 0
postoperative wound infection assessed by wound swab for microscopy and culture
Timepoint [3] 329621 0
six weeks postoperative
Secondary outcome [1] 403196 0
postoperative infectious morbidity in patients with prelabour rupture of membranes by seeing for the development of postoperative postoperative endometritis, fever and wound infection
Timepoint [1] 403196 0
six weeks postoperative

Eligibility
Key inclusion criteria
All patients who underwent emergency cesarean section at term i.e gestational age 37+0 to 41+6 weeks who were in labour for more than six hours, either booked or unbooked and with or without rupture of membranes.
Minimum age
15 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with preoperative fever >38°C, clinical features of chorioamnionitis, antepartum hemorrhage, severe anemia (hemoglobin less than 7g/dl), obstructed labor and those who failed to give consent were excluded.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomization
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
A total of 400 patients were observed using 95% confidence interval and 5% margin of error, under WHO software for sample size determination, with 200 patients in each group.
Data were analyzed using SPSS-20 statistical software. Quantitative variables like age and BMI was presented as median and interquartile range (IQR), while qualitative data such as postoperative fever, postoperative endometritis and wound infection were taken as frequency and percentages. Chi-square test was used to compare these complications in two groups. A p-value of less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
1/10/2017
Date of last data collection
Anticipated
Actual
14/11/2017
Sample size
Target
400
Accrual to date
Final
400
Recruitment outside Australia
Country [1] 24341 0
Pakistan
State/province [1] 24341 0
khyber pakhtoonkhwah

Funding & Sponsors
Funding source category [1] 310197 0
Hospital
Name [1] 310197 0
Women and children teaching hospital Bannu
Country [1] 310197 0
Pakistan
Primary sponsor type
Hospital
Name
Women and children teaching hospital Bannu
Address
Bannu, khyber pakhtoonkhwah, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 311285 0
None
Name [1] 311285 0
none
Address [1] 311285 0
none
Country [1] 311285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309876 0
ethical comittee, Bannu Teaching hospital
Ethics committee address [1] 309876 0
Bannu, Khyber Pakhtoonkhwah, Pakistan.
Ethics committee country [1] 309876 0
Pakistan
Date submitted for ethics approval [1] 309876 0
03/04/2017
Approval date [1] 309876 0
05/04/2017
Ethics approval number [1] 309876 0
206A

Summary
Brief summary
Objective: To see the effectiveness of preoperative vaginal cleansing with povidone-iodine in terms of frequency of post-operative infectious morbidity such as postoperative endometritis, fever and wound infections in patients undergoing emergency cesarean section, by conducting a randomized trial of 400 term patients, age 15-45 years, for more than six hours in labour, with or without rupture of membranes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115698 0
Dr Saida Abrar
Address 115698 0
Department of Gynaecology and Obstetrics, Lady Reading Hospital, Soekarno Roadd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000 Peshawar, Pakistan.
Country 115698 0
Pakistan
Phone 115698 0
+923329356845
Fax 115698 0
Email 115698 0
saidaabrar@gmail.com
Contact person for public queries
Name 115699 0
Dr Saida Abrar
Address 115699 0
Department of Gynaecology and Obstetrics, Lady Reading Hospital, Soekarno Roadd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000 Peshawar, Pakistan.
Country 115699 0
Pakistan
Phone 115699 0
+923329356845
Fax 115699 0
Email 115699 0
saidaabrar@gmail.com
Contact person for scientific queries
Name 115700 0
Dr Saida Abrar
Address 115700 0
Department of Gynaecology and Obstetrics, Lady Reading Hospital, Soekarno Roadd, PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000 Peshawar, Pakistan.
Country 115700 0
Pakistan
Phone 115700 0
+923329356845
Fax 115700 0
Email 115700 0
saidaabrar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participants data underlying published results
When will data be available (start and end dates)?
immediately after results publication with no end date determined
Available to whom?
case to case basis at discretion of primary sponsor
Available for what types of analyses?
IPD meta analysis
How or where can data be obtained?
principal investigator
email;saidaabrar@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14162Study protocol  saidaabrar@gmail.com through email from primary investigator
14163Statistical analysis plan  saidaabrar@gmail.com through email from primary investigator
14164Ethical approval  saidaabrar@gmail.com through email from primary investigator



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.