Methods |
Randomized, placebo controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Date of data collection: November 1983 and December 1984. |
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Setting: University Hospital, New Jersey; ; lower socioeconomic class (90% black) |
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Inclusion criteria: women < 21 years old undergoing CS. |
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Exclusion: antibiotic use within 2 weeks; active infection or fever at delivery; penicillin or sulfa allergy; internal fetal monitoring |
Interventions |
Trimethoprim 240 mg and sulfamethoxazole 1200 mg IV after clamping of cord (N = 29) vs placebo (N = 28) |
Outcomes |
Endomyometritis (fever [> 100.3°F twice within 24 hours after first day], uterine tenderness, absence of another focus); UTI (fever and positive culture); wound infection (fever, abnormal appearing wound with cellulitis or a wound draining purulent material) |
Notes |
Authors’ definition of high risk not comparable with that used in this review. |
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The incidence of UTI and wound infection was similar between the groups (numbers not given) |
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Class of antibiotic: sulfonamide/trimethoprim. |
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Subgroups:
type of CS unclear;
after cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
‘Randomly divided.’ |
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No further details provided. |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Unclear |
Placebo-controlled. |
All outcomes |
|
No further information. |
Incomplete outcome data addressed? |
Yes |
No loss to follow up reported. |
All outcomes |
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No participants excluded. |
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ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, gravidity, vaginal examinations, duration of labor and duration of rupture of membranes, elective repeat CS. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |