Methods |
Randomized, placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: July 1986-December 1987. |
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Setting: Grenoble, France. |
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Inclusion criteria: ‘low-risk’ women, undergoing CS (27% in labor) |
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Exclusion: allergy to beta-lactam antibiotics, receipt of antibiotics within 3 days; ruptured membranes >12 hours; fever, amniotic infection |
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Interventions |
Cefotetan 1 g IV at the time of cord clamping (N = 136) vs placebo injection (N = 130) |
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Outcomes |
Endometritis, wound infection (includes superficial wound infection and deep abscess), septicaemia; additional antibiotic use (10/136 in treatment group vs 19/130 in placebo) ; antibiotic costs; maternal hospital stay |
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Notes |
There was 1 episode of septicaemia in the placebo group. |
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Class of antibiotic: second generation cephalosporin (cefamycin) |
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Subgroups: |
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type of CS unclear;
after cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“…randomized by drawing of lots.” |
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Allocation concealment? |
Unclear |
No information provided. |
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Blinding? |
Yes |
Double blind, placebo-controlled. |
All outcomes |
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|
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Incomplete outcome data addressed? |
Yes |
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 reported as comparable regarding demographic values. Insufficient additional information |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |