Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

Study Overview
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Brief Summary
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The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.

Detailed Description
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Patiants and methods Randomization: Patients fulfilling the inclusion criteria will be randomized to two groups. Both two group will receive standard prophylaxis antibiotic CEFAZOLIN (zinol) (at a dose of 1 g) 2 hours preoperative. Control Group: This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative. Study Group: This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN) Inclusion criteria: Gestational age of 37 0/7 weeks and greater Elective cesarean section Medicaly free pregnant women Exclusion criteria: a known allergy to azithromycin obstetric complications azithromycin use within 7 days before randomization chorioamnionitis or other infection requiring postpartum antibiotic therapy Pre-gestational diabetes

Official Title
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ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S

Conditions
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Randomized Controll Trial

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age of 37 0/7 weeks and greater Elective cesarean section Medicaly free pregnant women Exclusion Criteria: a known allergy to azithromycin obstetric complications azithromycin use within 7 days before randomization chorioamnionitis or other infection requiring postpartum antibiotic therapy Pre-gestational diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control Group: This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative. Study Group: This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative. | Drug: Azithromycin<br>* In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.<br>* Other names: Cefazolin;|
| No Intervention: Study Group<br>This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometritis | Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus | 6 weeks after surgery |