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

Phase 1

• Conditions: Randomized Controll Trial
• Interventions: Drug: Azithromycin

• Registration Number: NCT03502356
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Last Update Submitted: 2018-04-11
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Study Start: 2018-04-20
• Primary Completion: 2018-06-20
• Study Completion: 2018-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Azithromycin	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams; 🇪🇬 Cairo, Elabasy, Egypt