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CTRI Number  CTRI/2024/08/072337 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 11/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of antibiotics in elective caesarean section 
Scientific Title of Study   Prophylactic versus regular use of antibiotics in elective caesarean section: A randomised controlled trial 
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 NEHA SINGH 
Designation  Junior Resident  
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY 
Address  Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh

Bareilly
UTTAR PRADESH
243006
India 
Phone  8930200022  
Fax    
Email  n.singh55@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr KANCHAN DALMIA 
Designation  PROFESSOR AND HEAD OF DEPARTMENT (Obstetrics and Gynaecology) 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY 
Address  Room no. 2027, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh

Bareilly
UTTAR PRADESH
243006
India 
Phone  9758463345  
Fax    
Email  kd91165@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr NEHA SINGH 
Designation  Junior Resident  
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY 
Address  Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh

Bareilly
UTTAR PRADESH
243006
India 
Phone  8930200022  
Fax    
Email  n.singh55@yahoo.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh  
 
Primary Sponsor  
Name  Dr NEHA SINGH 
Address  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr NEHA SINGH  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL  Department of Obstetrics and Gynaecology, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY
Bareilly
UTTAR PRADESH 
8930200022

n.singh55@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O860||Infection of obstetric surgical wound, (2) ICD-10 Condition: O861||Other infection of genital tract following delivery, (3) ICD-10 Condition: O862||Urinary tract infection followingdelivery, (4) ICD-10 Condition: O864||Pyrexia of unknown origin following delivery, (5) ICD-10 Condition: O868||Other specified puerperal infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ceftriaxone, metronidazole   Inj Ceftriaxone 1gm iv and Inj Metronidazole 500mg iv half hour before surgery. The second dose of Inj Ceftriaxone 1gm will be repeated after 12 hours 
Intervention  Ceftriaxone, Metronidazole, Cefuroxime   Inj Ceftriaxone 1 gm IV 12 hourly and Inj Metronidazole 500mg IV 8 hourly for a period of 48 hours Followed by Tab Cefuroxime 500mg per oral BD and Tab Metronidazole 400mg per oral TDS for 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All the patients opting for elective caesarean section, women undergoing primary and upto two previous caesarean sections, low risk antenatal females without any pre-existing medical illnesses, women having Hb of 9mg/dl or more, intra-operative blood loss less than 2 litres 
 
ExclusionCriteria 
Details  Premature rupture of membranes more than 12 hours, pre-existing infections, women who have hypersensitivity to cephalosporin s, operative procedure lasting more than 3 to 4 hours 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Febrile morbidity (fever), wound infection (infection of the surgical incision, redness, swelling, throbbing pain, pus, etc.), endometritis, UTI (urinary tract infection), uterine tenderness, foul smelling lochia  Till day 15 of discharging the patient from hospital 
 
Secondary Outcome  
Outcome  TimePoints 
DURATION OF HOSPITAL STAY  AT DISCHARGE 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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   N/A 
Date of First Enrollment (India)   22/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Women who fulfil the criteria for inclusion and exclusion will be counselled and an informed consent will be taken for participation in the research. After getting patient’s consent, a thorough history will be taken and clinical examination including general examination, systemic examination, and obstetric examination will be done. All the ANC investigations will be sent if not already done (CBC, ABORh, HIV, HCV, HBsAg, VDRL, Urine routine microscopy, USG Obs, single step OGTT with 75gm glucose, TSH, T3, T4 and urine C/S). In booked cases we will repeat CBC and urine routine microscopy if it is not done recently that is within 1 week.

 A structured questionnaire will be used to get a focussed history from the subjects. The patients will be randomly allocated in 2 groups A and B by lottery method. All the patients will be tested for hypersensitivity to Inj. Ceftriaxone 1 hour before surgery. The Group A will receive prophylactic antibiotics that is Inj. Ceftriaxone 1gm iv and Inj. Metronidazole 500mg iv half hour before surgery. The drug will be given by the anaesthetist in the operation theatre and the labour room staff will be kept unaware about the regime. The second dose of ceftriaxone will be repeated after 12 hours. The Group B will be administered Inj Ceftriaxone 1 gm iv 12hourly and Inj Metronidazole 500mg 8 hourly for a period of 48 hours followed by Tab cefuroxime 500mg BD and Tab Metronidazole 400mg TDS per oral for 5 days.

A close eye will be kept for any signs and symptoms of infection. In case any suspicion of infection arises, a thorough clinical examination will also be done to localise the source of infection and investigations will be sent according to the site of infection.

Any appearance of discharge from the wound, along with localized swelling, warmth, and tenderness, with or without microbiological proof, will be considered as a wound infection. In this case a complete blood count and wound swab for culture & sensitivity will be sent.

Patient developing fever and burning micturition will be taken as urinary tract infection. For these cases, urine for routine microscopy and urine for culture and sensitivity will be sent.

Postoperative fever (i.e. temperature of higher than 38oC on two or more occasions, separated by minimum of 4 hours, but not within the first 24 hours following a caesarean section), tachycardia, uterine tenderness or offensive lochia with or without other symptoms will be taken as signs of clinical endometritis. An endocervical swab will be taken for microscopy, culture and sensitivity testing in these patients.

 If the CBC report indicates an infection in the Group A subject, the patient will be started on a regular antibiotic regimen of Tab Cefuroxime 500mg twice daily and Tab Metronidazole 400mg TDS until the culture and sensitivity report is ready. If there isn’t a clinical improvement and the sensitivity report indicates that the aforementioned antibiotics aren’t working, then the antibiotics will be changed accordingly in both groups. Check dressing will be done on post-operative day 4 and sutures will be removed on day 7. We will follow up the patient 15 days after discharging the patient or earlier if any problems like pain, fever, burning micturition or any abnormal discharge.

 
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