Randomized Controll Trial
Conditions
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 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
Interventions
DRUGAzithromycin
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention 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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endometritis | 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 |
Countries
Egypt
Contacts
Primary Contactmohamed 20 amar, md
Outcome results
None listed