Huam 1997.
Methods | Quasi‐RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: September 1994 to April 1995. Setting: University Hospital, Kuala Lumpur, Malaysia. Inclusion criteria: elective CS. Exclusion criteria: allergic to penicillin, evidence of infection, premature rupture of membranes, receiving antibiotics prior to CS. |
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Interventions |
Intervention:
Comparison: no treatment:
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Outcomes | Febrile morbidity (fever > 38°C twice at least 4 hrs apart after the 1st 24 hrs); wound sepsis (defined and graded as a) erythema and/or induration, b) serous oozing, c) presence of pus, d) wound dehiscence); UTI (routine midstream urine on 3rd post‐operative day > 100,000 organisms/mL); endometritis (fever, uterine tenderness and foul smelling lochia); pneumonia (cough, fever and/or radiographic evidence of pulmonary consolidation). | |
Notes |
Class of antibiotic: beta‐lactamase inhibitor combination. Subgroups:
"Both the study groups and control group were comparable in terms of patient characteristics and operative variables." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Alternately allocated to either antibiotic group or control group". Comment: quasi‐RCT. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss of participants to follow‐up; no participant excluded after analysis; ITT analysis. |
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. |