ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Ain Shams University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- endometritis
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Azithromycin (Drug)
Outcomes
Primary Outcomes
endometritis
Time Frame: 6 weeks after surgery
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
Secondary Outcomes
No secondary outcomes reported
Investigators
mohamed abd elhamied abd elgaber
cario egypt
Ain Shams University