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

Phase 3

Not yet recruiting

Conditions: Sequelae of complication of pregnancy, childbirth, and the puerperium,

Registration Number: CTRI/2023/05/053292

Lead Sponsor: DR VINDHYAVALI NANNURI

Brief Summary: STUDIES SUGGEST THAT AZITHROMYCIN BASED EXTENDED PROPHYLAXIS SINGLE DOSE AZITHROMYCIN AND STANDARD CEPHALOSPORINS PROPHYLAXIS MAY REDUCE THE RISK OF POSTOPERATIVE INFECTIONS AND IS ALSO COST EFFECTIVE

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 520

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe for	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
endometritis	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
surgical site infection like wound gaping,serous discharge and purulent discharge	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
fever cough	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
erythema of skin,cellulitis,induration	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
unscheduled visits,readmissions	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
length of hospital stay	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 Outcome Measures

Name	Time	Method
sepsis	RDS

Trial Locations

Locations (1): SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
🇮🇳
Bijapur, KARNATAKA, India
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
🇮🇳Bijapur, KARNATAKA, India
VINDHYA
Principal investigator
8464806595
reddy.vindhyavali@gmail.com