Methods |
Randomized placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: January 1970 to June 1980. |
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Setting: Washington, DC. US. |
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Inclusion criteria: women undergoing CS who were not in labor and did not have ruptured membranes (elective) |
Interventions |
Ampicillin 1 g 30 min prior to surgery and at 4 and 8 hours post-operatively (N = 42) vs placebo solution (N = 40) |
Outcomes |
Febrile morbidity (> 100.4 °F twice 6 hours apart after the first 24 hours); endomy-ometritis (fever, uterine and adnexal tenderness, purulent lochia); UTI; wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 1/42 vs placebo 6/40); maternal hospital stay (4.3 vs 4.6; no variance given) |
Notes |
No life-threatening infection related complications nor bacteremic episodes in either group |
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Class of antibiotic: aminopenicillin (ampicillin). |
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Subgroups:
elective CS;
before cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
Randomized. |
|
|
No further information. |
Allocation concealment? |
Unclear |
No information was provided. |
Blinding? |
Unclear |
Described as “double-blind”. Placebo-controlled: “placebo solution”. |
All outcomes |
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Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
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No participant 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, race, gravidity, parity and socioeconomic status. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |