Tully 1983.
Methods | Randomized, placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual placebo‐controlled; double‐blind. |
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Participants | Dates of data collection: September 1978 to June 1980. Setting: Beth Israel Hospital, Boston, Massachusetts, US. Inclusion criteria: women undergoing primary CS (inclusion criteria not consistent with the definition of non‐elective CS used in this review). N = 113. Exclusion criteria: < 18 years of age, membranes ruptured > 35 hrs, allergy to penicillin or cephalosporin, fever, infection or antibiotic use, significant underlying cardiac, renal or hepatic disease, unable to provide consent. |
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Interventions |
Intervention: cefamycin:
Comparison: placebo:
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Outcomes | Febrile morbidity (oral temperature > 37.9oC twice at least 6 hrs apart after 1st 24 hrs); UTI (positive culture); wound infection (purulence, cellulitis or dehiscence); endometritis (fever, uterine tenderness, abnormal lochia); septicemia (positive blood culture in a clinically septic patient); additional antibiotic use (8 in treatment group vs 12 in placebo). | |
Notes | Both episodes of septicemia occurred in the placebo group. Class of antibiotic: cefamycin (2nd generation cephalosporin). Subgroups:
The 2 groups were comparable regarding age, BMI, gravidity, frequency of fetal monitoring, number of vaginal examinations, duration of labor, duration of ruptured membranes, duration of surgery and indications for CS. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomized as determined by table of random numbers. |
Allocation concealment (selection bias) | Low risk | Comment: sequential study numbers. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up reported; 14 women (7 in each group) initially randomized were later excluded (all doses not administered, antibiotic therapy prior to surgery, antibiotic following surgery, incorrect dose schedule, infection prior to surgery, drug code broken for possible allergy. 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 | Comment: randomization was blind to both patients and investigators. Placebo‐controlled (mannitol with riboflavin). |
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. |