Prophylactic versus regular use of antibiotics in elective caesarean section: A randomised controlled trial

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.