Shah 1998.
Methods | RCT; 4 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not reported. Setting: United Arab Emirates. Inclusion criteria: women undergoing elective CS (definition not provided). N = 198. 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 |
Intervention: penicillin (A3):
Intervention: penicillin (A3):
Intervention: drug combination [cephalosporin (B1) plus nitroimidazole (I)]:
Comparison: no treatment:
Results of the 2 penicillin treatment groups were combined for this review. Placebo data were divided: 2/3 for comparison with penicillin (A) and 1/3 for comparisons with the cephalosporin. |
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Outcomes | Febrile morbidity (fever > 38oC twice 4 hrs apart after 1st day); endometritis (uterine and parametrial tenderness, foul smelling vaginal discharge); wound infection (local induration and tenderness with wound exudate). | |
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. Class of antibiotic: extended spectrum penicillin (ureidopenicillin (pipericillin)) vs other combination (1st generation cephalosporin plus nitroimidazole (metronidazole). Subgroups:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...randomized..". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Low risk | Quote: "...consecutively numbered sealed envelopes..". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 14 women were excluded (8/147 from treatment groups, 6/51 from control group). As‐treated analysis with available outcome data. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding, not placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: probably outcome assessment was not blinded. |
Other bias | Low risk | Comment: no other sources of bias identified. |