Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: September 1977-January 1978. |
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Setting: State Maternity Hospital, Helsinki, Finland. |
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Inclusion criteria: all women undergoing CS. |
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Exclusion criteria: allergic to penicillin, clindamycin or gentamicin; emergency section |
Interventions |
10 million units benzyl penicillin IV (N = 46) vs 500 mg clindamycin IV and 80 mg gentamicin IM (N = 42) vs glucose solution placebo (N = 40) IV by infusion starting 30 minutes before operation and stopping 4 hours after. Results of both treatment groups combined |
Outcomes |
Endometritis (fever, uterine tenderness and foul-smelling vaginal discharge); wound infection (all grades combined); hospital stay (treatment 7.7 vs 7.7 placebo; no variance given) |
Notes |
Data from a fourth group that consisted ofpatients allergic to 1 ofthe drugs or undergoing an emergency section have not been included |
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Drug class: penicillin or lincosamide (clindamycin) and aminoglycoside |
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Subgroups:
type of CS unclear;
before cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“Assigned at random … in bottles containing code numbers.” |
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No further information provided. |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Yes |
Placebo-controlled. |
All outcomes |
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“the code was kept secret for persons performing the operations and observing the patients in the post-operative period.” |
Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. |
All outcomes |
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Two women excluded after initial randomization. |
|
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ITT analysis with available data. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The first 3 groups were comparable regarding number of amnioscopic examinations, number of vaginal examination, duration of labor and duration of intrauterine monitoring. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |