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

Randomized Controll Trial Clinical Trial

Official title:

ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03502356
• Other study ID #: 2377
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 11, 2018
• Last updated: April 11, 2018
• Start date: April 20, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: April 2018
• Source: Ain Shams University
• Contact: mohamed 20 amar, md
• Phone: 01024706467
• Email: drmohamed145[@]gmil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Randomized Controll Trial

Intervention

Drug:
• Azithromycin
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.

Locations

Country	Name	City	State
Egypt	Ain Shams	Cairo	Elabasy

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometritis	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	6 weeks after surgery