Ruiz‐Moreno 1991.
Methods | Randomized, placebo‐controlled; 2 parallel groups. Unit of randomization: individual. |
|
Participants | Dates of data collection: not reported. Setting:Hospital Central Militar, Mexico city, Mexico. Women predominantly (78%) of low socioeconomic level. Inclusion criteria: women in active labor undergoing CS. N = 100. Exclusion: elective CS, evidence of infection, antibiotic use within 8 days, metronidazole intolerance, lack of consent. |
|
Interventions |
Intervention: nitroimidazole:
Comparison: placebo:
Immediately after cord clamping. |
|
Outcomes | Endometritis (purulent and/or foul odor lochia); wound infection (wound edges tender, red and swollen, or frank pus or sanguino‐purulent material exuded); UTI (bacteria seen in sediment); maternal hospital stay. | |
Notes |
Class of antibiotic: nitroimidazole (metronidazole). Subgroups:
The 2 groups reported as comparable regarding age and parity, etc. |
|
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 | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no losses or exclusions were reported. Appears to be ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: double‐blind; identical appearing placebo. |
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. |