Methods |
RCT: 2 parallel groups. |
|
Unit of randomization: individual. |
Participants |
Women undergoing elective CS (absence of labor and before rupture of membranes). |
|
Exclusion: allergy to penicillin or cephalosporin, prior antibiotic therapy within 7 days. |
|
Setting: United Arab Emirates. |
Interventions |
Cefuroxime 1.5 g after clamping of the cord vs no treatment. |
Outcomes |
Febrile morbidity (temperature of > 38°C after first 48 hours); endometritis (uterine tenderness and offensive lochia with fever and no other source); wound infection (erythema, induration or purulent discharge); UTI (> 100,000 bacteria/ml) |
Notes |
Majority of patients were indigent; follow up at 6 weeks. |
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Class of antibiotic: second generation cephalosporin. |
|
Subgroups:
elective CS;
after cord clamping.
|
Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
“…a computer generated number scheme…” |
Allocation concealment? |
Unclear |
Although “…randomization code and the mode of intervention was only known to the anesthesiology staff…” there is still insufficient information to judge allocation concealment |
Blinding? |
Yes |
Not placebo controlled, but “patient and study co-ordinators unaware of group allocation” |
All outcomes |
|
|
|
The mode of intervention was only known to the anesthesiology staff. So those assessing outcomes were not aware of allocation |
Incomplete outcome data addressed? |
Unclear |
No losses or exclusions were reported. Analysis appears to be ITT |
All outcomes |
|
|
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, parity, weight, gestational age and indication for cesarean. Insufficient information overall |
Overall low risk of bias? |
Unclear |
Mostly unclear, particularly allocation concealment. |