Evaluation of the effect of adding vaginal lavage with betadine to routine abdominal lavage on infection after cesarean section
Design
This study is a non-blinded clinical trial with a parallel design and a control group. The study population will include all women who are candidates for cesarean section referring to Imam Reza hospital in Kermanshah. 170 eligible people will be selected conveniently. Random blocks are used for randomization and participants are assigned to two intervention and control groups .
Settings and conduct
This study is a non-blinded clinical trial. All patients will be prescribed prophylactic antibiotics before the umbilical cord clamp.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women candidates for repeat and non-repeat cesarean section; Singleton; Gestational age of 37 weeks and above
Exclusion criteria: Allergy to betadine; Emergency cesarean section
Placenta previa, diabetes; Long-lasting labor and mothers undergoing frequent vaginal examinations; AIDS patients
Intervention groups
In the intervention group, in addition to routine washing of the abdominal skin with betadine, vaginal washing with betadine is performed before cesarean section. Rinsing is done with two 10% betadine-soaked gauzes, each of which is rotated 360 degrees inside the vagina so that rinsing the vagina with each gauze will take 30 seconds. Abdominal lavage will be performed with 10% betadine and three betadine-impregnated gauzes. The lavage will begin in a concentric rotation from the abdominal incision and extend from the inside to the outside. The total washing time will be 5 minutes. In the control group, routine abdominal skin washing with 10% betadine and three betadine-impregnated gauzes will be performed.
Main outcome variables
Wound infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N166
Registration date:2021-04-12, 1400/01/23
Registration timing:prospective
Last update:2021-04-12, 1400/01/23
Update count:0
Registration date
2021-04-12, 1400/01/23
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding vaginal lavage with betadine to routine abdominal lavage on infection after cesarean section
Public title
Evaluation of the effect of adding vaginal lavage with betadine to routine abdominal lavage on infection after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for repeat and non-repeat cesarean section
Singleton
Gestational age of 37 weeks and above
Exclusion criteria:
Allergy to betadine
Emergency cesarean section
Placenta previa, diabetes
Disposal of meconium
Long-lasting labor and mothers undergoing frequent vaginal examinations
AIDS patients
Patients with immunosuppressive diseases
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
ir.kums.rec.1399.1139
Health conditions studied
1
Description of health condition studied
cesarean wound complications, such as disruption or infection
ICD-10 code
Y83.8
ICD-10 code description
Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Wound infection
Timepoint
Beginning of the study, 6 weeks after surgery
Method of measurement
doctor checkup
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, in addition to routine washing of the abdominal skin with betadine, vaginal washing with betadine is performed before cesarean section. Rinsing is done with two 10% betadine-soaked gauzes, each of which is rotated 360 degrees inside the vagina, so that rinsing the vagina with each gauze will take 30 seconds. Abdominal lavage will be performed with 10% betadine and three betadine-impregnated gauzes. The lavage will begin in a concentric rotation from the abdominal incision and extend from the inside to the outside. The total washing time will be 5 minutes
Category
Treatment - Other
2
Description
In the control group, routine abdominal skin washing with betadine will be performed. Abdominal lavage will be performed with 10% betadine and three betadine-impregnated gauzes. The lavage will begin in a concentric rotation from the abdominal incision and extend from the inside to the outside. The total washing time will be 5 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Khadijeh Rahmani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
yas2934@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Khadigeh Rahmani
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
yas2934@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Anisodoleh Nankali
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
anankali@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Khadigeh Rahmani
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
yas2934@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available