Roex 1986.

Methods	Randomized, placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual.
Participants	Dates of data collection: April 1983 to October 1984. Setting: Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, The Netherlands. Inclusion criteria: all women undergoing CS (77/129 were elective sections). N = 129. Exclusion: active infection, antibiotics within 7 days, allergy to penicillin or cephalosporin, impaired liver or renal function.
Interventions	Intervention: cefamycin: cefoxitin 2 g; N = 64. Comparison: placebo: matching placebo; N = 65. IV bolus immediately following clamping of the cord and at 6 and 12 hrs later.
Outcomes	Febrile morbidity (> 38oC for at least 24 hrs after 1st 24 hrs); endometritis (fever, fetid lochia and/or uterine tenderness on pelvic examination); wound infection (palpable induration, wound dehiscence and/or pus drained); UTI (positive culture), bacteremia.
Notes	1 episode of Staphylococcus aureus bacteremia (in cefoxitin group) not considered life‐threatening (included in outcome of serious morbidity). No serious antibiotic side effects reported in cefoxitin‐treated group; 1 patient in cefoxitin group developed diarrhea. Class of antibiotic: cefamycin (2nd generation cephalosporin). Subgroups: both elective and non‐elective CS; after cord clamping. The 2 groups were comparable regarding demographic, obstetric and operative factors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomly allocated". Comment: no description of sequence generation process.
Allocation concealment (selection bias)	Unclear risk	Commentt: no information provided.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: 21 women were excluded: 2 had fever prior to surgery, 2 because of a known allergy to penicillins; 8 women excluded because of protocol failures and 9 women for intraoperative complications (not defined further); as‐treated 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, placebo‐controlled.
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.