| 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
|
|
|
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
|
|
|
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. |