Polk 1982.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: July 1978 to October 1980. Setting: Brigham and Women's Hospital, Boston, Massachusetts, US. Inclusion criteria: all women undergoing CS (other than repeat section); criteria do not correspond with our definition of non‐elective. N = 278. Exclusion: active infection, fever, membranes ruptured > 36 hrs, antibiotic therapy within 2 weeks, renal disease, allergy to penicillin or cephalosporin. |
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Interventions |
Intervention: 1st generation cephalosporin:
Comparison: placebo:
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Outcomes | Fever (oral temperature > 100.3oF on any of 2 of 1st 10 post‐operative days); UTI, wound infection (only pus‐draining included in outcome of wound infection); endometritis (fever, tenderness on pelvic examination, abnormal discharge); pelvic abscess; septic pelvic thrombophlebitis, bacteremia; subsequent antibiotic use (23% for placebo vs 12% for treatment). | |
Notes | Outcome of fever and minor wound infection combined (11/146 for treatment vs 13/132 for placebo).
4 episodes of bacteremia, all in placebo group.
1 episode of rash and 1 episode of phlebitis reported in treatment group vs none in control.
Data collected at 6 weeks on 259/266 patients; 35% of infections diagnosed after discharge. Class of antibiotic: 1st generation cephalosporin. Subgroups:
The 2 groups were comparable regarding age, BMI, proportion on private service, etc. |
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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: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 12 participants withdrawn (8 treatment, 4 placebo) and started on therapeutic antibiotics by the surgeon because the operation had been prolonged or was complicated or the pre‐operative specimen of urine disclosed significant bacteriuria; results on participants excluded 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 | Low risk | Quote: "Participants, their physicians and all investigators were unaware of the assignment throughout the study". Comment: double‐blind, matching placebo. |
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. |