Lemus 2005.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Date of data collection: not reported. Setting: Hospital de Ginecologia y Obstetrcia num. 3 del Centro Medico La Raza, Mexico City, Mexico Inclusion criteria: women who had undergone CS with: no risk factors for wound infection at the time of the operation; no UTI or cervicovaginitis; intact membranes; less than 6 vaginal examination before the operation; no allergy to beta‐lactam antibiotics; clean surgical procedure without prolonged stage of labor (less than 33 minutes); primary closure of the incision; no use of drains. Exclusion criteria: women with medical factors that would lead to inadequate wound healing (diabetes, obesity, malnutrition); post‐surgical factors (asthma, pulmonary complications, coughing and vomiting after surgery); ascites; anemia; history of radiotherapy; anesthetic complications requiring intensive care admission; corticosteroid use; incomplete follow‐up. |
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Interventions |
Intervention 1:
Intervention 2:
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Outcomes | Wound infection (follow‐up until day 30); definition of wound infection unclear. | |
Notes | Translated from Spanish Class of antibiotic: 3rd generation cephalosporin. Subgroups:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: Women were allocated "at random and sequentially, but non‐random" as it depended on the obstetrician to start the prophylaxis perioperatively. |
Allocation concealment (selection bias) | High risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: women with incomplete follow‐up were excluded. |
Selective reporting (reporting bias) | Unclear risk | Comment: no information provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding; not placebo‐controlled; obstetrician started prophylaxis. |
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. |