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IRCT20210415050982N1 IRCT 2021-05-26 Qazvin University of Medical Sciences Effect of vaginal preparation with chlorhexidine before cesarean section on the rate of endometritis and post operative wound infection 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 2021-04-29 anticipated 320 Complete https://irct.ir/trial/55876 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A endometritis and post operative wound infection in the pregnant women undergoing cesarean section. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nasibeh Parsaei athar
Daneshgah Street
Qazvin Iran (Islamic Republic of) 5981134197 +98 912 246 7846 Ngo1366@yahoo.com Qazvin University of Medical Sciences scientific Nasibeh Parsaei athar
Daneshgah Street
Qazvin Iran (Islamic Republic of) 5981134197 +98 912 246 7846 Ngo1366@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) All pregnant women with cesarean section indication no limit no limit Female Diabetes Chorioamnionitis Severe anemia Meconium excretion Multiple pregnancy (Twin and more) Long-term rupture of bladder (more than 18 hours) O86.12 Endometritis following delivery Prevention Prevention 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. 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. 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. 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. Qazvin University of Medical Sciences Approved 2021-02-21 Ethics Committee of Qazvin University of Medical Sciences Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)