D'Angelo 1980.
Methods | RCT; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not stated. Setting: Cleveland, Ohio, USA. Inclusion criteria: women in labor with ruptured membranes requiring internal monitoring (non‐elective delivery). N = 80. Exclusion criteria: evidence of infection; penicillin or cephalosporin allergy. |
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Interventions |
Intervention 1: cephalosporin:
Intervention 2: cephalosporin:
Comparison: no treatment:
Short and long courses of cephalosporins combined for this review. Administered after umbilical cord clamping. |
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Outcomes | Endometritis and/or wound infection (antibiotic 12/49 vs control 20/31). | |
Notes | It was possible to deduce the rate of endometritis alone, but not wound infection, for this review.
1 late infectious complication (wound dehiscence) in control group. Drug class: 1st generation cephalosporin. Subgroups:
There were no statistical differences among the 3 groups for potential risk factors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote:"Randomly assigned". Comment: 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 of participants to follow‐up; no participants excluded after analysis. ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding of participant or clinician; 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. |