Health Condition 1: O860- Infection of obstetric surgical wound
Conditions
Interventions
Intervention1: Injection azithromycin 500mg along with a 1g cefotaxime injection: Addition of Injection Azithromycin 500mg intravenous along with a 1g injection of Cefotaxime within 1 hour of the surg
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to participate with signed informed consent 2. Maternal age >19 years 3. Women undergoing primary or repeat lower-segment caesarean delivery
Exclusion criteria
Exclusion criteria: 1. Known allergy to cephalosporin or azithromycin 2. Use of antibiotics in the 72 hours prior to caesarean section 3. Chorioamnionitis, or any other active bacterial infection (e.g. pyelonephritis, pneumonia or abscess) at the time of randomization 4. Immunocompromising medical conditions: HIV positive with CD4 count below 200, chronic steroid use, current diagnosis of cancer and/or chemotherapy agent use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of surgical site infection within 30 days after delivery: Presence of either superficial or deep incisional surgical-site infection characterized by wound induration and discharge from the wound within 30 days after delivery.Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of endometritis within 30 days after delivery: 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 discharge from the uterus within 30 days after delivery. 2. Maternal postpartum readmission or unscheduled visits due to sepsis within 30 days after delivery: Admission to the hospital or unscheduled visit due to SSI or endometritis within 30 days after delivery. 3. An additional antibiotic requirement in the postoperative period: Antibiotic use for any reason including other infections such as UTI and sepsis within 30 days after delivery. 4. Microorganisms identified in wound culture and their sensitivity to antibiotics. 5. Neonatal Intensive Care Unit (NICU) admissions due to neonatal sepsis within 30 days.Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactGarima wadhwa
Aiims New Delhi
Outcome results
None listed