Evaluation the effect of azithromycin prophylaxis on decreasing the rate of post-operative infection in female candidates for elective cesarean section

Evaluation of the effect of azithromycin prophylaxis on decreasing the rate of post-operative infection in female candidates for elective cesarean section

This study is a single-blinded clinical trial with a parallel design and a control group. The study population will include all depressed patients referred to the psychiatric ward of Ayatollah Modarres hospital of Isfahan. The number of 84 eligible patients will be selected conveniently. A random number table is used for randomization and participants are assigned to two intervention and control groups.

This study is a single-blinded clinical trial. In such a way that participants are unaware of the allocation of study groups. The two groups will be matched based on age, body mass index, and gravidity. All mothers are given prophylaxis cefazolin of 1 gram within 30-60 minutes before cesarean section.

Inclusion criteria: Gestational age over 37 weeks; Selective cesarean section candidates; No history of the previous infection; No sensitivity to the understudy antibiotics Exclusion criteria: Smoker mothers; Corticosteroid users; Pre-pregnancy diabetes; Preeclampsia; Premature rupture of membranes; Gestational diabetes; Mothers taking azithromycin within 7 days of surgery

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

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.

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.