| CTRI Number |
CTRI/2024/04/065067 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Azithromycin and ceftriaxone verses ceftriaxone alone in a case of prelabour cesarean birth to decrease surgical site infection |
|
Scientific Title of Study
|
Randomised controlled trial between single dose Azithromycin and ceftriaxone verses ceftriaxone alone in a case of prelabour cesarean birth to decrease surgical site infection |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh baburao Munde |
| Designation |
PGT MS OBGY 2ND YEAR |
| Affiliation |
Institute of postgraduate medical education and research Kolkata |
| Address |
Department of obgy Labour room NEAR operation theatre A.J.C. BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
dryogeshbmunde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Gouri Sankar kamilya |
| Designation |
Professor MS OBGY DNB OBGY |
| Affiliation |
Institute of postgraduate medical education and research Kolkata |
| Address |
IPGMER SSKM KOLKATA A J C BOSE ROAD KOLKATA 700020
Department of obgy Room no 4
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433122643 |
| Fax |
|
| Email |
drgkamilya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Gouri Sankar kamilya |
| Designation |
professor MS OBGY DNB OBGY |
| Affiliation |
Institute of postgraduate medical education and research Kolkata |
| Address |
IPGMER SSKM KOLKATA A J C BOSE ROAD KOLKATA 700020
Department of obgy Room no 4
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433122643 |
| Fax |
|
| Email |
drgkamilya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of postgraduate medical education and research Kolkata |
|
|
Primary Sponsor
|
| Name |
Dr. Yogesh baburao Munde |
| Address |
Sskm doctors hostel 210 A.J.c. Bose road Kolkata 700020 |
| 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 |
| Dr Yogesh baburao Munde |
IPGMER SSKM KOLKATA |
Ipgmer sskm kolkata a j c Bose
Department of obgy Labour room road Kolkata 700020
Kolkata
WEST BENGAL |
7066398363
dryogeshbmunde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnancy |
| Patients |
(1) ICD-10 Condition: O860||Infection of obstetric surgical wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Azithromycin and ceftriaxone |
Azithro 500 mg and ceftriaxone 1gm both intravenous |
| Comparator Agent |
On ceftriaxone |
Ceftriaxone 1gm stat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant after 37 weeks with indication breech, previous c-ection,
placenta previa |
|
| ExclusionCriteria |
| Details |
Allergy to Azithromycin,contraindications,women in active labour, preterm labour,twins
,Maternal condition |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduce surgical site infection
2.reduce endometritis
3.improve maternal and neonatal outcomes
4.safety profile |
Once weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evidence based practice
Advancement of knowledge |
Evidence based practice according to response
Advancement of knowledge side effects weekly |
|
|
Target Sample Size
|
Total Sample Size="1980"
Sample Size from India="1980"
Final Enrollment numbers achieved (Total)= "198"
Final Enrollment numbers achieved (India)="198" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomised controlled trial between single dose Azithromycin and ceftriaxone alone verses ceftriaxone alone in a case of prelabour cesarean birth , Purpose to decrease surgical site infection. |