Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT03502356
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: