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. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3

Lemus 2005.

Methods RCT; 2 parallel groups.
Unit of randomization: individual.
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.
Interventions Intervention 1:
  • cefotaxime 1 g every 8 hrs x 24 hrs;

  • N = 500.


Intervention 2:
  • no treatment;

  • N = 500.

Outcomes Wound infection (follow‐up until day 30); definition of wound infection unclear.
Notes Translated from Spanish
Class of antibiotic: 3rd generation cephalosporin.
Subgroups:
  • elective CS (based on inclusion criteria stating labor of less than 33 minutes);

  • after cord clamping (women had undergone CS).

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.