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IRCT20190526043710N1 IRCT 2019-08-05 Sabzevar University of Medical Sciences Comparison of efficacy of anitibitic befor and after C/S to prevent post_cesarean infection Comparison of efficacy of prophylactic antibiotic prescribing before cesarean section and antibiotic administration after cord clamping on prevention of post-cesarean infection 2019-06-14 anticipated 180 Complete https://irct.ir/trial/39985 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Simple Random unit: Individual Randomization Tool: Random Number Tables How to create a random sequence: A random number table using www.randomization.com Hiding: Hiding in this study will be done by the central service and people who do not have any information about the research, Blinding description: Patients will be treated by prescription drug packs (which are quite similar in appearance).Patient and executor are not aware of the contents of packages. Information gathering, patient assessment and completion of the forms will be carried out by the executor and her assistant who are not aware of the contents of packages. The data analysis will also be done by the statistician who is not aware of packages contents and only is aware of the grouping (group 1 or 2). Therefore, the study is a triple blinded study and the patient's arrival stage to the study, data collection and analysis, the contents of the packs will not be determined. 3 Comparison of efficacy of antibiotic prescribing before and after cesarean section. Intervention 1: Intervention group: 90 pregnant mothers eligible for inclusion in the study will be prescribed antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) after clamping the umbilical cord and Distilled water one hour before making the cut (cesarean section). Intervention 2: Control group: 90 pregnant mothers eligible for inclusion in the study will be taken antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With a weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) One hour before making the cut (cesarean section) and distilled water immediately after cord clamping. 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 Zeinab Shahbazzadeh
No. 41, Alaei Sagharloo Alley, West 194 Ave, Tehranpars third Square, Tehranpars Town
Tehran Iran (Islamic Republic of) 1653888344 +98 21 7773 4246 shahbazzadeZ90@medsab.ac.ir Sabzevar University of Medical Sciences scientific Dr. Mitra Eftekhar Yazdi
Sabzevar Shahidan Mobini hospital, North Kashefi Ave
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4423 8100 m_eftekhari1144@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Pregnant women who undergo C/S due to midwifery indications or other reasons Providing informed consent no limit no limit Female Having underlying dieases (DM, liver dieases, kidney dieases, suppressd immune sys) The presence of chorioamnionitis criteria (loshia, tenderness, fever) Fever (oral temperature above 38 degrees) Rupture of memberans more than 24 hours Immunosuppressive drugs use (corticosteroids and etc) Use of antibiotics 24 hours before cesarean section Prevention Prevention Intervention group: 90 pregnant mothers eligible for inclusion in the study will be prescribed antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) after clamping the umbilical cord and Distilled water one hour before making the cut (cesarean section). Control group: 90 pregnant mothers eligible for inclusion in the study will be taken antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With a weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) One hour before making the cut (cesarean section) and distilled water immediately after cord clamping. Incidence of post Cesarean infection. Timepoint: During the Hospitalization and 10 or 14 days after cesarean section. Method of measurement: Physical examination and judgment. Sabzevar University of Medical Sciences Approved 2019-05-25 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohidshahr Blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)