Methods |
RCT; 4 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: not reported. |
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Setting: United Arab Emirates. |
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Inclusion criteria: women undergoing elective CS (definition not provided) |
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Exclusion: hypersensitivity to penicillin or cephalosporin; prior antibiotic therapy within 3 days; hepatorenal insufficiency; positive cultures or definite evidence of infection |
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Interventions |
Pipericillin 4 g IV after the cord was clamped (N = 48) vs cephradine 500 mg plus metronidazole 500 mg both IV after the cord was clamped and every 8 hours × 2 (N = 47) vs piperacillin 2 g IV after clamping of the cord and 2 g every 8 hours × 2 (N = 52) vs no treatment (N = 51) |
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Outcomes |
Febrile morbidity (fever > 38°C twice 4 hours apart after first day); endometritis (uterine and parametrial tenderness, foul smelling vaginal discharge); wound infection (local induration and tenderness with wound exudate) |
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Notes |
3 women who developed drug reactions were excluded from study (1 from each of the treatment groups). Late morbidity evaluated at 4-6 weeks |
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Class of antibiotic: Ureidopenicillin (pipericillin). |
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Subgroups: |
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elective CS;
after cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“… randomized…” |
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Allocation concealment? |
Unclear |
“…consecutively numbered sealed envelopes…” but as sequence generation was unclear, so allocation concealment will be unclear |
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Blinding? |
Unclear |
No information was provided. |
All outcomes |
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|
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Incomplete outcome data addressed? |
Unclear |
No losses were reported but 14 women were excluded (8/147 from treatment groups, 6/51 from control group). It was an ITT analysis but with available outcome data |
All outcomes |
|
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
Insufficient information to judge. |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |