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IRCT20130812014333N160 IRCT 2021-01-15 Kermanshah University of Medical Sciences Evaluation the effect of azithromycin prophylaxis on decreasing the rate of post-operative infection Evaluation the effect of azithromycin prophylaxis on decreasing the rate of post-operative infection in female candidates for elective cesarean section 2021-01-04 anticipated 84 Complete https://irct.ir/trial/53396 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: In this study, participants are unaware of the allocation of study groups. In such a way that the participants, despite their satisfaction and awareness of participating in the study, are unaware of the allocation of study groups. 2-3 Infection following cesarean section. Intervention 1: The intervention group will receive 500 mg of oral azithromycin manufactured by Farabi company in addition to the standard protocol (cefazolin 1 g, intravenously manufactured by Farabi company ). Intervention 2: The control group will receive a placebo in addition to the standard protocol (Cefazolin 1 intravenously, manufactured by Farabi company ). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Maryeh Rezaei
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 Drmaryeh@gmail.com Kermanshah University of Medical Sciences scientific Dr. Anisodoleh Nankali
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 anis_nankali@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Gestational age over 37 weeks Selective cesarean section candidates No history of previous infection No sensitivity to the under study antibiotics no limit no limit Female Smoker mothers Corticosteroid users Pre-pregnancy diabetes Preeclampsia Premature rupture of membranes Gestational diabetes Mothers taking azithromycin within 7 days of surgery T81.4 Infection following a procedure Treatment - Drugs Treatment - Drugs The intervention group will receive 500 mg of oral azithromycin manufactured by Farabi company in addition to the standard protocol (cefazolin 1 g, intravenously manufactured by Farabi company ). The control group will receive a placebo in addition to the standard protocol (Cefazolin 1 intravenously, manufactured by Farabi company ). Wound infection rate. Timepoint: From the time of hospitalization to the time of stitches removal, the first week after surgery and 6 weeks after surgery. Method of measurement: Asking from the patient. Kermanshah University of Medical Sciences Approved 2020-12-22 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)