Stage 1982.
Methods | Randomized, placebo‐controlled trial; 2 parallel groups (2:1 active:placebo randomization). Unit of randomization: individual. Part of a larger study looking at prophylaxis also in gynecologic surgery. |
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Participants | Dates of data collection: July 1976 to June 1978. Setting: 14 US centers. Inclusion criteria: all women undergoing CS (46% in labor). N = 199. Exclusion criteria: infection, allergy to penicillin or cephalosporins. |
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Interventions |
Intervention: 1st generation cephalosporin:
Comparison: placebo:
Within 1 hr prior to surgery, repeated at 4 hrs. |
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Outcomes | Febrile morbidity (oral temperature > 37.7oC twice 4 hrs apart, after 1st 48 hrs); endometritis (uterine tenderness, fever and purulent discharge), wound infection (increased local tenderness, redness or swelling); UTI (positive culture); maternal length of stay (treatment 5.8 days vs placebo 7.57 days; P < 0.05, variance not given). | |
Notes |
Class of antibiotic: 1st generation cephalosporin. Subgroups:
The 2 groups were comparable regarding age and other risk factors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly allocated". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: investigator provided with Individually. randomized block of patient numbers. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: dropouts in CS women not stated (overall: 11/319 from treated group, 8/172 from placebo group. As‐treated analysis performed. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: placebo‐controlled; patients and investigators blind to allocation throughout the study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: probably outcome assessment was blinded. |
Other bias | Low risk | Comment: no other sources of bias identified. |