Heilmann 1984.
Methods | Randomized trial; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not stated. Setting: Essen, Germany. Inclusion criteria: women undergoing CS in labor (classified as non‐elective). Exclusion criteria: none reported. |
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Interventions |
Intervention 1:
Intervention 2:
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Outcomes | Febrile morbidity (oral temperature > 30°C for at least 2 days); wound infection (reported as "healing difficulties" in translation of table); UTI (105 bacteria/mL after removal of the catheter); length of post‐operative stay. | |
Notes | Translated from German. Class of antibiotic: cefamycin (2nd generation cephalosporin). Subgroups:
The groups were comparable for age, weight, duration of operation, birthweight, duration of urinary catheter use, premature rupture of membranes > 12 hrs; intrauterine fetal monitoring; birthweight. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "open randomization". Comment: no additional information provided; no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up; analysis was ITT. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding; not placebo‐controlled. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: probably outcome assessment was not blinded. |
Other bias | Low risk | Comment: no other sources of bias identified. |