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

Ain Shams University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Randomized Controll Trial

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03502356

2377

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Azithromycin

Study Group

No Intervention group

Description:

This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)