Scarpignato 1982.
Methods | RCT; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: November 1981 to March 1982. Setting: University of Parma, Parma, Italy. Inclusion criteria: women undergoing emergency CS (58/60 women in spontaneous labor; classified as non‐elective). N = 60. Exclusion criteria: allergy to penicillin or cephalosporins; severe renal disease, history of pelvic infections. |
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Interventions |
Intervention: 2nd generation cephalosporin:
Intervention: cephalosporin (B2):
Comparison: no treatment:
The results of both treatment groups have been combined. |
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Outcomes | Fever (> 100.3oF twice 6 hrs apart); endometritis (fever and uterine tenderness); maternal stay (treatment 7.1 vs control 7.9 days, no variance given). | |
Notes | Note: the group given long‐term prophylaxis received the 1st dose after return to the ward. Class of antibiotic: 2nd generation cephalosporin. Subgroups:
The 3 groups were comparable. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information was provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no losses to follow‐up reported. 1 woman was excluded because of an allergic reaction to cefuroxime. Could not be re‐included in 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. |