Methods |
RCT: 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: not specified. |
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Setting: Durban, South Africa. |
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Inclusion criteria: all patients undergoing CS. |
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Exclusion criteria: women with pre-existing UTI. |
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Interventions |
Ampicillin 500 mg IM pre-operatively and 8 hourly for 48 hours followed by 500 mg orally 8 hourly for 4 days (N = 150) vs no treatment for first 48 hours then oral placebo 8 hourly for 4 days (N = 150) |
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Outcomes |
UTI (culture positive), intra-uterine infection not defined further, classified as endometri-tis), wound infection |
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Notes |
Fewer postpartum urinary isolates in treated group were sensitive to ampicillin (8/17 vs 18/26). |
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In the control group, 3 women developed pelvic abscesses (included as serious morbidity) and 1 patient required hysterectomy for secondary postpartum haemorrhage following severe E. coli intrauterine infection |
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Class of antibiotic: aminopenicillin (ampicillin). |
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Subgroups: |
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type of CS unclear;
before cord clamping.
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Risk of bias |
|
Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“on a random basis.” |
|
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Method not described. |
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Allocation concealment? |
Unclear |
Insufficient information to judge. |
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Blinding? |
Unclear |
Partly placebo controlled: “an oral placebo was given after 48 hours” |
All outcomes |
|
|
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Insufficient information to judge whether there was blinding of study personnel |
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Incomplete outcome data addressed? |
Yes |
No loss of participants to follow up. |
All outcomes |
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No participant excluded after randomization. |
|
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ITT analysis. |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
insufficient information to judge. |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |