SAFETY AND EFFICACY OF ADDING SINGLE DOSE ADJUNCTIVE AZITHROMYCIN PROPHYLAXIS FOR EMERGENCY CESAREAN DELIVERY

safety and efficacy of adding single dose adjunctive azithromycin prophylaxis for emergency ceserean delivery

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053292

Enrollment

520

Registered

2023-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

Interventions

Intervention1: AZITHROMYCIN: INJECTION AZITHROMYCIN 1GRAM IV IN 250ML NORMAL SALINE STAT WITH IN 30 TO 60MINS BEFORE SKIN INCISION Control Intervention1: Placebo therapy: For comparison, a placebo (25

Eligibility

Inclusion criteria

Inclusion criteria: 1.Singleton pregnancy. 2.Gestational age of 28 weeks or more. 3.Patients undergoing emergency cesarean section. 4.After membrane rupture within 12 hours or PROM 5.All primigravida or multigravida with singleton pregnancy undergoing emergency lscs

Exclusion criteria

Exclusion criteria: 1.patients who are unable to provide consent 2.known allergy to azithromycin 3.Use of azithromycin 7 days before randomization 4.chorioamniotis,fever,urinary tract infection,requiring postpartum antibiotic therapy 5.In patients with liver diseases,increased serun creatinine level of >2.0mg/dl 6.patients in need of dialysis 7.cardiomyopathy,pulmonary edema,known case of electrolyte abnormalities 8.PROM more than 12 hours

Design outcomes

Primary

Measure	Time frame
To observe for endometritis surgical site infection like wound gaping,serous discharge and purulent discharge fever cough erythema of skin,cellulitis,induration unscheduled visits,readmissions length of hospital stayTimepoint: To observe for endometritis surgical site infection like wound gaping,serous discharge and purulent discharge fever cough erythema of skin,cellulitis,induration unscheduled visits,readmissions length of hospital stay will be checked for all these on 3rd,7th,14th postoperative day and 6th week	—

Measure

Time frame

To observe for endometritis surgical site infection like wound gaping,serous discharge and purulent discharge fever cough erythema of skin,cellulitis,induration unscheduled visits,readmissions length of hospital stayTimepoint: To observe for endometritis surgical site infection like wound gaping,serous discharge and purulent discharge fever cough erythema of skin,cellulitis,induration unscheduled visits,readmissions length of hospital stay will be checked for all these on 3rd,7th,14th postoperative day and 6th week

—

Secondary

Measure	Time frame
sepsis RDS periventricular leucomalacia,intraventricular hemorrhage SIRS bronchopulmonary dysplasia duration of NICU stayTimepoint: to observe for 6 weeks	—

Countries

India

Contacts

Public ContactDR SHOBHA SHIRAGUR

SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER

reddy.vindhyavali@gmail.com8464806595

Outcome results

None listed

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