Fugere 1983.
Methods | Randomized, placebo‐controlled trial; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: September 1980 to November 1981. Setting: Hopital Saint‐Luc, Montreal, Canada. Inclusion criteria: women undergoing non‐elective CS. N = 89. Exclusion criteria: not in labor with intact membranes, allergy to cephalosporins, antibiotic use within 48 hrs, fever, ruptured membranes for > 36 hrs. |
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Interventions |
Intervention:
Intervention:
Comparison: placebo:
At clamping of the cord and at 6 and 12 hrs later. Placebo group was divided 1/2 and for comparison with the 2 treatment groups. |
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Outcomes | Endometritis, wound infection, UTI (symptoms or 2 successive positive cultures) septicemia, pelvic abscess, pelvic thrombophlebitis. Follow‐up at 6 weeks. No side effects observed. | |
Notes | There were no serious infections in any of the groups.
In the placebo and cefazolin groups there was no increase in aerobic bacterial colonization of the cervix after 4 days but there was an increase in colonization by anaerobes; the opposite occurred in the group receiving cefoxitin. Class of antibiotic: 1st generation cephalosporin vs cefamycin (2nd generation cephalosporin). Subgroups:
The groups were comparable regarding demographic characters. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Quote: "A number (1 to 90) identified the boxes. The number was allocated randomly to a box". Comment: an envelope containing the randomization code was available in case of adverse reactions. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no loss to follow‐up; 1 patient in the control group was excluded from analysis as no cultures were performed; as‐treated analysis performed. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind"..... "vitamin solution with a similar colour as the other preparations". Comment: placebo‐controlled. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to judge. |
Other bias | Low risk | Comment: no other sources of bias identified. |