| CTRI Number |
CTRI/2023/05/053292 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
SAFETY AND EFFICACY OF ADDING SINGLE DOSE ADJUNCTIVE AZITHROMYCIN PROPHYLAXIS FOR EMERGENCY CESAREAN DELIVERY |
|
Scientific Title of Study
|
safety and efficacy of adding single dose adjunctive azithromycin prophylaxis for emergency ceserean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VINDHYAVALI NANNURI |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD-2 DEPARTMENT OF OBGY
SHRI BM PATIL MEDICAL CLG HOSPITAL AND RESEARCH CENTRE
Bijapur
KARNATAKA
586103
India |
| Phone |
8464806595 |
| Fax |
|
| Email |
reddy.vindhyavali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINDHYAVALI NANNURI |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD-2 DEPARTMENT OF OBGY
SHRI BM PATIL MEDICAL CLG HOSPITAL AND RESEARCH CENTRE
OPD-2
DEPARTMENT OF OBGY
SHRI BM PATIL MEDICAL CLG HOSPITAL AND RESEARCH CENTRE
Bijapur
KARNATAKA
586103
India |
| Phone |
8464806595 |
| Fax |
|
| Email |
reddy.vindhyavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHOBHA SHIRAGUR |
| Designation |
PROFESSOR |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD-2 DEPARTMENT OF OBGY
SHRI BM PATIL MEDICAL CLG HOSPITAL AND RESEARCH CENTRE
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shobha.shiragur@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| DR VINDHYAVALI NANNURI
OPD NO 2 SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
BANGARAMMA SAJJAN CAMPUS VIJAYAPURA
BIJAPUR
KARNATAKA
586103
INDIA |
|
|
Primary Sponsor
|
| Name |
DR VINDHYAVALI NANNURI |
| Address |
OPD NO 2 SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
BANGARAMMA SAJJAN CAMPUS VIJAYAPURA
BIJAPUR
KARNATAKA
586103
INDIA |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VINDHYA |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
OPD NO.2
DEPARTMENT OF OBGY
Bijapur
KARNATAKA |
8464806595
reddy.vindhyavali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,BLDE(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AZITHROMYCIN |
INJECTION AZITHROMYCIN 1GRAM IV IN 250ML NORMAL SALINE STAT WITH IN 30 TO 60MINS BEFORE SKIN INCISION |
| Comparator Agent |
Placebo therapy |
For comparison, a placebo (250ml normal saline) will be given instead of azithromycin along with already existing antibiotic protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
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
|
| Outcome |
TimePoints |
sepsis
RDS
periventricular leucomalacia,intraventricular hemorrhage
SIRS
bronchopulmonary dysplasia
duration of NICU stay |
to observe for 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |