Adjunctive Azithromycin prophylaxis for cesarean delivery

Phase 4

Not yet recruiting

• Conditions: Infection of obstetric surgical wound,

• Registration Number: CTRI/2022/12/048571
• Lead Sponsor: Yuktha Khanna

Brief Summary

There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV.

Group B will receive the standard antibiotic prophylactic drug Xone 1G IV along with injection Azithromycin 500mg IV. The primary outcome of surgical site infection will be compared and studied between 2 groups.The women will be followed up until the day of discharge for any induration,redness and discharge at the surgical infection site

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-27
• Study Start: 2023-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 256

Inclusion Criteria

Pregnant women with a singleton pregnancy at gestational age of 28 weeks or more who are to undergo Cesarean section.

Exclusion Criteria

• 1)patients who are not willing to give consent 2)patients with underlying liver disease, chorioamnionitis or any other infection.
• 3)Patients with known structural heart disease or arrthymias .
• 4)Patients taking any medications known to prolong the QT interval 5)use of antibiotics 7 days prior to randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV.	1 year
Group B will receive the standard antibiotic prophylactic drug Xone 1G IV along with injection Azithromycin 500mg IV.	1 year
PRIMARY OUTCOME-	1 year
The primary outcome of surgical site infection will be compared and studied between 2 groups until the period of discharge from hospital	1 year

Trial Locations

Locations (1)

Jawaharlal Nehru Medical College and medical research centre; 🇮🇳 Belgaum, KARNATAKA, India

Jawaharlal Nehru Medical College and medical research centre

🇮🇳Belgaum, KARNATAKA, India

Yuktha khanna

Principal investigator

9600809703

yuktha.scorpio94@yahoo.in