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Adjunctive Azithromycin prophylaxis for cesarean delivery

Azithromycin as an adjunct prophylactic drug for prevention of SSI in cesarean delivery -A Randomised Control Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048571
Enrollment
256
Registered
2022-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O860- Infection of obstetric surgical wound

Interventions

Intervention1: Injection Azithromycin 500mg IV will be given slowly over a period of 15-30 minutes within 0-60 minutes prior to incision: There will be 2 groups .Group A will receive the standard ant

Sponsors

Yuktha Khanna
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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. PRIMARY OUTCOME- The primary outcome of surgical site infection will be compared and studied between 2 groups until the period of discharge from hospital Timepoint: 1 year

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactYuktha khanna

Jawaharlal Nehru Medical College and medical research centre

anitamgan@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026