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. 2014 Nov 17;2014(11):CD008726. doi: 10.1002/14651858.CD008726.pub2

Kamilya 2012.

Methods RCT two parallel treatment groups, women randomised individually.
Participants Inclusion criteria
  • Women undergoing CS, elective or emergency.

  • N = 760 randomised with 746 analysed.


Exclusion criteria
  • Women known to be hypersensitive to any of the trial drugs; any antibiotic treatment 2 weeks prior to surgery; presence of chorioamnionitis; diabetes; malnutrition; obesity, >85 kg; immuno‐compromised state; > 3 times per vaginal examination for intrapartum cases; prolonged preoperative hospitalisation and duration of labor > 6 hours.

Interventions Intervention: cephalosporin (B3).
  • Cefotaxime 1 g single dose intravenous.

  • Just after clamping the umbilical cord.

  • Total number randomised: N = 380 but 372 analysed.


Comparison: penicillin (A4) combination.
  • Amoxicillin–clavulanic acid combination 1.2 g single dose IV.

  • Just after clamping the umbilical cord.

  • Total number randomised: N = 380 but 374 analysed.

Outcomes Febrile morbidity, wound healing, endometritis, side effects of antibiotics.
Reported outcomes: “fever, mild or moderate wound infection, endometritis, UTI or any serious infection, fever in the 5th post‐operative period, adverse reactions, duration of hospital stay. ”
Notes Setting
Tertiary care teaching hospital in Kolkata, India.
Subgroups
  1. Both elective and emergency CS.

  2. After cord clamping.

  3. Systemic ‐ IV.

  4. Single dose.

  • Comparisons 1 (subgroup 2); 2; 3; 4; 10.

  • No information about funding source of trial.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “Randomization was done a priori by computer in blocks of 40.”
Allocation concealment (selection bias) Unclear risk "The randomization list remained in the custody of the principal investigator."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk “Being a double blind study, the nature or medication being received by individual trial subjects was not known to the subject or the project clinician”.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk “Being a double blind study, the nature or medication being received by individual trial subjects was not known to the subject or the project clinician”. It seemed most likely considering the outcomes assessed that assessors were blinded as well.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk “A total of 760 patients were recruited for the study. Eight patients in the cefotaxime group and six patients in the
amoxicillin–clavulanic acid group had to be excluded from final analysis for various reasons”.
Selective reporting (reporting bias) Unclear risk The study protocol is unavailable.
Other bias Unclear risk Baseline characteristics were similar for: age; parity; gestation. Other possible biases were unclear.
No information about funding source of trial.