Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: not reported. |
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Setting: Tripler Army Medical Center, Honolulu, Hawaii, US. |
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Inclusion criteria: all women undergoing CS (19/60 women had ruptured membranes > 6 hours; 40/60 were in active labor) |
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Exclusion: known infection, currently on antibiotics, allergic to penicillin or cephalosporin |
Interventions |
Cefamandole 2 g in 800 ml normal saline irrigation (N = 30) vs irrigation with 800 ml normal saline (N = 30). Non-irrigation control group (N = 30) not included in analysis |
Outcomes |
Endomyometritis (fever, unusual uterine and parametrial tenderness without evidence of other source of infection); maternal length of stay |
Notes |
Length ofhospital stay for the control group included results from both the no irrigation group and the placebo irrigation group (5.37 days vs 4.53 for treatment group) |
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Class of antibiotic: second generation cephalosporin. |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
Randomly allocated using table of random numbers. |
Allocation concealment? |
Yes |
Randomly allocated by hospital pharmacy. |
Blinding? |
Yes |
Double-blind, placebo-controlled. |
All outcomes |
|
Vitamin solution added to make placebo visually identical; physicians and patients blinded to treatment |
Incomplete outcome data addressed? |
Yes |
No losses were reported. |
All outcomes |
|
No participants excluded. |
|
|
ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 3 groups were comparable regarding age, parity, weight and socioeconomic background. Insufficient information overall |
Overall low risk of bias? |
Yes |
Mostly low risk of bias. |