Methods |
Quasi-RCT, 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection; not reported. |
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Setting: Hammersmith Hospital (N = 102) and Northwick Park Hospital (N = 99), London, England |
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Inclusion criteria: women undergoing CS (both elective and emergency) |
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Exclusion: on antibiotics, adverse reaction to penicillin or cephalosporin, pyrexia > 37.5 degrees C in labor, known vaginal pathogen, or suspected intrauterine infection |
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Interventions |
Cephradine 2 g IV after induction of anesthesia and 1 g 6 and 12 hours after the operation (N = 101) vs no treatment (N = 100) |
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Outcomes |
Puerperal infection (temperature > 37.5°C after 24 hours); endometritis (pyrexia with uterine or adnexal tenderness); wound infection (purulent discharge or erythema, induration and serous discharge with positive culture); UTI (> 100,000 colony forming units in urine culture); length of hospital stay (7.63 for treatment group, 7.18 for control group [SD not provided]) |
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Notes |
Definitions of elective and emergency procedure, nor separate outcomes for each group, provided. |
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Follow up completed 1987. |
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Class of antibiotic: first generation cephalosporin. |
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Subgroups: |
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Risk of bias |
|
Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
No |
“…alternate patients…” |
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Allocation concealment? |
No |
“…alternate patients…” |
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Blinding? All outcomes |
Unclear |
No information was provided. |
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Incomplete outcome data addressed? |
Unclear |
No losses or exclusions were reported. Analysis appears to be ITT |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The 2 groups were comparable with respect to age, social class, single mother, weight, previous CS, the mode of onset of labor, the use of electronic fetal monitoring, the type of CS, gestational age, birthweight or the perinatal outcome. Insufficient information overall |
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Overall low risk of bias? |
Unclear |
Quasi-RCT indicates high risk of bias. |