Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

Phase 4

Completed

• Conditions: Wound Sepsis
• Interventions: Drug: cephalosporin; Drug: Azithromycin Tablets

• Registration Number: NCT04062175
• Lead Sponsor: Ain Shams University

Brief Summary

efficacy of adding azithromycin to cephalosporin before cesarean delivery

Detailed Description

efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Study Timeline

• Study Start: 2019-03-20
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-18
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-18
• Last Update Submitted: 2019-08-18
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• age between 17 and 39 years
• gestaional age between 37 to 42 weeks
• elective cesarean delivery
• obese women

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Exclusion Criteria

• diabetic women on corticosteroids
• intraopertaive complication in previous section
• history of septic woun
• prelabour rupture of membrane >12 hours

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cephalosporin +azithromycin arm	Azithromycin Tablets	72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
cephalosporin +azithromycin arm	cephalosporin	72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
cephalosporin arm	cephalosporin	72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision

Primary Outcome Measures

Name	Time	Method
% of women with wound infection	after 14 days post cesarean delivery	superficial and deep surgical site wound infection will be looked for by laboratory confirmation

Secondary Outcome Measures

Name	Time	Method
% of women with postpartum endometritis	after 14 days post cesarean delivery	fever, abdominal pain , uterine tenderness will be looked for

Trial Locations

Locations (1)

Ain Shams maternity hospital; 🇪🇬 Cairo, Egypt