Methods |
Randomized placebo controlled trial; 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dats of data collection: not reported. |
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Setting: Jersey City Medical Center, New Jersey; predominantly lower socio-economic indigent women Inclusion criteria: women |
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undergoing primary CS after onset of labor (corresponds to the definition of non-elective) |
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Exclusion: febrile or infected, allergy to pipericillin. |
Interventions |
Pipericillin 4 g peri-operatively (N = 50) vs pipericillin 4 g peri-operatively and at 4 and 8 hours post-operatively (N = 50) vs placebo (N = 50); both treatment groups combined in analysis |
Outcomes |
Febrile morbidity (> 38.0°C twice at least 6 hours apart after first post-operative day) ; endometritis (fever, tender uterus and purulent lochia); hospital stay (no significant difference, variance not given) |
Notes |
Use of saline or antibiotic lavage not allowed. |
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No adverse reactions reported with treatment. |
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Class of antibiotic: ureidopenicillin (pipericillin). |
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Subgroups:
non-elective CS;
after cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“…randomly divided…” |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Unclear |
Described as blinded. |
All outcomes |
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Incomplete outcome data addressed? |
Unclear |
No losses or exclusions were reported. The analysis appears to be by ITT |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 3 groups were comparable regarding number of vaginal exams, haemoglobin levels and other risk factors. However, there was insufficient information to judge overall |
Overall low risk of bias? |
Unclear |
Unclear. |