Hager 1983.
Methods | Randomized, placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not reported. Setting: Central Baptist Hospital, Lexington, Kentucky, US. Inclusion criteria: women undergoing primary, non‐elective CS (while it appears most women were in labor and/or had ruptured membranes it is unclear whether all patients fulfilled our criteria for non‐elective). N = 90. Exclusion: antibiotic use within 7 days, penicillin or cephalosporin allergy. |
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Interventions |
Intervention:
Comparison: placebo:
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Outcomes | Infectious morbidity (fever > 100.3oF twice 6 hrs apart after 1st 24 hrs); endomyometritis (fever, uterine tenderness, and positive culture from endometrium); wound infection, UTI; maternal duration of stay (treatment 5.1 days vs placebo 5.4; not significant, no variance given). | |
Notes | There was 1 episode of bacteremia in the control group. Class of antibiotic: 2nd generation cephalosporin. Subgroups:
The 2 groups were comparable regarding age, race, parity, weight, type of anesthesia, operating time or pre‐operative hematocrit. |
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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: "according to pre‐numbered envelopes maintained in the central pharmacy". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up; no participant excluded; ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind".... "identical appearing, equal volume solution". |
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. |