Efficacy of vaginal cleansing in reducing postoperative infection after Cesarean Delivery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 96 patients (in each group).
Settings and conduct
Pregnant women candidates for caesarean section referred to three hospitals of Imam Reza (AS), Qaim (AS) and Umm al-Binin (S) of Mashhad who meet the inclusion criteria will be randomly included in the study.
Before the cesarean section, the demographic information of the patients will be recorded in checklists. In addition, after the cesarean section, the duration of the operations will be recorded. Whether vaginal washing has been done or not will be specified and completed in a sealed envelope for each patient by the caesarean operator.
Participants/Inclusion and exclusion criteria
Criteria for entering:
1. People with indications for cesarean section 2. Informed consent to enter the study.
Exclusion criteria:People with chorioamnionitis, heavy bleeding from placental abruption, betadine allergy, and active genital herpes.
Intervention groups
In the intervention group of patients before surgery the entire vagina are washed of gauze soaked in 10% betadine . In the control group, caesarean section will be performed routinely. Caesarean section will be performed in the same way in all participants.
Main outcome variables
Wound infection in one day, one week and 6 weeks after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240713062414N1
Registration date:2024-08-03, 1403/05/13
Registration timing:prospective
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Elahe Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 0126
Email address
elahe.salari63@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of vaginal cleansing in reducing postoperative infection after Cesarean Delivery
Public title
Efficacy of vaginal cleansing in Cesarean Delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All woman with cesarean indications
Obtaining informed consent to enter the study
Exclusion criteria:
Women with chorioamnionitis
Allergy for povidon iodine
Vaginal bleeding from placenta previa
Active genital herpes
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
205
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by random block method with blocks of 4 and using random numbers table of Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The ratio of allocation of samples will be 1:1 and they will be placed in two groups.
The method is that we determine the number of blocks according to the sample size. Each block is numbered and used for 4 patients.
For example, if block number 2 is selected in the lottery and its treatment group is ABAB, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patients, they will not be given any information about whether vaginal cleansing was done or not. In order to blind the evaluators of the research team, as soon as the intervention or control group is determined in the randomization stage, a random code will be assigned to the participants and the participants will be tracked through that code in all stages of the research (without including group A or B on the file). Finally, after evaluating the results, the codes will be decoded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad univercity of medical sciences
Street address
Mashhad-univercity street-ghoreishi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9515745769
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.395
Health conditions studied
1
Description of health condition studied
postoperative infection after Cesarean Delivery such as:endometritis
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
2
Description of health condition studied
postoperative infection after Cesarean Delivery such as:wound infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people who have wound infection
Timepoint
Wound infection that will be checked one day,one week,and six weeks after surgery
Method of measurement
Physical examination and vaginal exam with speculum and thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: cesarean section will be performed routinely in these people
Category
Other
2
Description
Intervention group: in the intervention group of preoperative patients in addition routine and abdominal prep & drep of the entire vagina and anterior and posterior fornix by two pieces of gauze soaked in 10% betadine solutionThe face is washed 360 degrees for 1 minute.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Salameh Dadgar
Street address
Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۵۱۱۱۲۳۴۵۲
Phone
+98 51 3876 0126
Email
Elahe.salari63@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Salameh Dadgar
Street address
Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۵۱۲۳۴۵۴۳۲
Phone
+98 51 3876 0126
Email
Elahe.salari63@gmail.com
3
Recruitment center
Name of recruitment center
Ommolbanin hospital
Full name of responsible person
Salameh Dadgar
Street address
Ayatolah Bahjat St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91447 34756
Phone
+98 51 3223 1061
Email
Elahe.salari63@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ebn-e sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
۳۴۵۶۷۵۴۳۲۳
Phone
+98 51 3876 0126
Email
Elahe.salari63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research assistan
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
Mashhad University of Medical Sciences
Full name of responsible person
Salameh Dadgar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ebn-e sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
2345654323
Phone
+98 51 3876 0126
Email
Dadgars@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Salari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
5678769876
Phone
+98 51 3876 0126
Email
Elahe.salari63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Salari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad-ghaem hospital-gynecology and obstetrics departman
City
Mashhad
Province
Razavi Khorasan
Postal code
4565434567
Phone
+98 51 3876 0126
Fax
Email
Elahe.salari63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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When the data will become available and for how long
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