Kamilya 2012.
Methods | RCT two parallel treatment groups, women randomised individually. | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: cephalosporin (B3).
Comparison: penicillin (A4) combination.
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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. ” |
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Notes |
Setting Tertiary care teaching hospital in Kolkata, India. Subgroups
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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. |