Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

Wound Sepsis Clinical Trial

Official title:

Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062175
• Other study ID #: 55
• Status: Completed
• Phase: Phase 4
• Start date: March 20, 2019
• Est. completion date: July 18, 2019

Study information

• Verified date: August 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

efficacy of adding azithromycin to cephalosporin before cesarean delivery

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 18, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 39 Years

Eligibility

Inclusion Criteria:

• age between 17 and 39 years

• gestaional age between 37 to 42 weeks

• elective cesarean delivery

• obese women

Exclusion Criteria:

• diabetic women on corticosteroids

• intraopertaive complication in previous section

• history of septic woun

• prelabour rupture of membrane >12 hours

Related Conditions & MeSH terms

• Wound Sepsis

Intervention

Drug:
• cephalosporin
72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of women with wound infection	superficial and deep surgical site wound infection will be looked for by laboratory confirmation	after 14 days post cesarean delivery
Secondary	% of women with postpartum endometritis	fever, abdominal pain , uterine tenderness will be looked for	after 14 days post cesarean delivery