Kristensen 1990.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: February 1987 to March 1988. Setting: Odense University Hospital, Denmark. Inclusion criteria: women undergoing non‐elective CS (58/201 without labor; 65/201 without ruptured membranes). N = 201. Exclusion: fever, antibiotics within 7 days, penicillin or cephalosporin allergy. |
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Interventions |
Intervention: 2nd generation cephalosporin:
Comparison: no treatment:
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Outcomes | Febrile morbidity (> 37.9oC twice at least 6 hrs apart after 1st post‐operative day); endometritis (fever, uterine tenderness and abnormal lochia); wound infection (fever, cellulitis and/or purulent discharge); UTI; cost of post‐operative antibiotics (treatment $US0.69 vs control $US7.47); maternal hospital stay (treatment 8.1 vs control 8.0, no variance given). | |
Notes | No woman had a severe infection such as pelvic abscess or septic pelvic thrombophlebitis. Class of antibiotic: 2nd generation cephalosporin. Subgroups:
The 2 groups were comparable regarding epidemiologic and obstetric data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...randomly..". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Quote: "envelopes containing empty vial or vial containing treatment". Comment: insufficient information to judge. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no losses or exclusions were reported. The analysis appears to be by ITT. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Patients, attending physicians, and study coordinators were blind with regard to group assignments". Comment: not placebo‐controlled; insufficient information to judge. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to judge. |
Other bias | Low risk | Comment: no other sources of bias identified. |