Protocol summary

Study aim
Determining the effect of vaginal lavage with chlorhexidine before cesarean section on endometritis and wound infection after cesarean section
Design
This study is a randomized controlled clinical trial (RCT). The method of random allocation will be block randomization. The minimum sample size in each group was calculated to be 140, and with 15% attrition rate was calculated 160 in each group. Patients during the first 10 days after cesarean section will be examined for symptoms of endometritis (fever 38.8 ° C or higher after 24 hours after surgery) and infection of the incision site (redness or opening of the wound edges with the appearance of purulent discharge).
Settings and conduct
This study was performed in the surgical ward of Kowsar Hospital in Qazvin city in Qazvin province. Blinding: One-way blindness Description of how to blind: Abdominal and vaginal washing will be done in two groups by the researcher. The researcher will be unaware of which group the samples are in.
Participants/Inclusion and exclusion criteria
Inclusion criterion: All mothers who had a cesarean section indication. Non-inclusion criteria: diabetes; Existence of severe chorioamnionitis; Excretion of meconium; Twin pregnancies and more; Prolonged rupture of the bladder (more than 18 hours).
Intervention groups
Intervention group: In addition to rinsing the abdomen with betadine and injecting antibiotics, rinsing with sterile gas containing 0.05% chlorhexidine around and inside the vaginal opening for 45 seconds and rotating 360 degrees will be performed and receive vaginal preparation. Control group: Before starting cesarean section, abdominal rinsing with Betadine and antibiotic injection will be performed. Patients will also receive vaginal lavage with normal saline.
Main outcome variables
Occurrence of endometritis; Abdominal incision site infection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210415050982N1
Registration date: 2021-05-26, 1400/03/05
Registration timing: registered_while_recruiting

Last update: 2021-05-26, 1400/03/05
Update count: 0
Registration date
2021-05-26, 1400/03/05
Registrant information
Name
Nasibeh Parsaii athar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 6380
Email address
ngo1366@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-29, 1400/02/09
Expected recruitment end date
2022-04-29, 1401/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vaginal prep with chlorhexidine in comparison with normal saline before cesarean section on endometritis and post operative wound infection in the pregnant women undergoing cesarean section
Public title
Effect of vaginal preparation with chlorhexidine before cesarean section on the rate of endometritis and post operative wound infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women with cesarean section indication
Exclusion criteria:
Diabetes Chorioamnionitis Severe anemia Meconium excretion Multiple pregnancy (Twin and more) Long-term rupture of bladder (more than 18 hours)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 320
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. To perform this method, the size of each block is specified at first (for example, a quadruple block). Then we write a list of blocks and assign numbers to them. (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then we select random numbers between one and 6 (For example, 1 4 5, etc.) and finally specify the treatment allocation list based on previous random numbers (… AABB-BBAA-BABA-).} The same procedure continues until the sample size is completed. In this way, from among the mothers of 320 people who have the inclusion criteria, they will be selected by convenience and will be divided into two groups of test and control by random block method (160 people in each group).
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that abdominal and vaginal lavage will be performed in two groups by the researcher, endometritis and wound infection will be performed according to the mentioned criteria and the researcher will be unaware of that which sample belongs to each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
5981134197
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.QUMS.REC.1399.490

Health conditions studied

1

Description of health condition studied
endometritis and post operative wound infection in the pregnant women undergoing cesarean section
ICD-10 code
O86.12
ICD-10 code description
Endometritis following delivery

Primary outcomes

1

Description
Occurrence of endometritis
Timepoint
Patients will be evaluated for signs of endometritis (fever 38.8 ° C or higher 24 hours after surgery) during the first 10 days after cesarean section.
Method of measurement
check list

2

Description
Abdominal incision site infection
Timepoint
During the first 10 days after cesarean section, patients will be examined for infection of the incision site (redness or opening of the wound edges with the removal of purulent discharge).
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to abdominal rinsing with betadine and antibiotic injections, rinsing with 0.05% chlorhexidine-impregnated sterile gas will be performed around and inside the vaginal opening for 45 seconds and rotated 360 degrees to receive vaginal preparation.
Category
Prevention

2

Description
Control group: Before starting cesarean section, abdominal rinsing with Betadine and antibiotic injection will be performed. Patients will also receive vaginal lavage with normal saline.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital, Ghazvin province
Full name of responsible person
Nasibeh Parsaei athar
Street address
Daneshgah Street
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3333 6001
Email
Ngo1366@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nasibeh Parsaei athar
Street address
Daneshgah Street
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3333 6001
Email
Ngo1366@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Nasibeh Parsaei athar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshgah Street
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 912 246 7846
Fax
Email
Ngo1366@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nasibeh Parsaei athar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshgah Street
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 912 246 7846
Email
Ngo1366@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nasibeh Parsaei athar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshgah Street
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
0989122467846
Email
Ngo1366@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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