Ziogos 2010.
Study characteristics | ||
Methods | Prospective RCT ‐ 2 parallel arms ‐ women randomised individually. | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: 2nd generation cephalosporin (C2)
Comparator: broad spectrum penicillin plus betalactamase inhibitor (P2+)
Subgroups
Comparisons: 1; 2 (subgroup 3); 3 (subgroup 2) |
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Outcomes |
Outcomes: the primary outcome was development of an infection either at the surgical site or elsewhere, e.g. UTI, endometritis. Reported outcomes: postoperative infections, surgical site infection (SSI), endometritis, duration of hospitalisation in days median (IQR), duration of hospitalisation postoperatively in days median (IQR), adverse drug reactions. |
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Notes |
Study dates July 2004 to December 2008 Setting Major tertiary care hospital, Nikaia’s Regional General Hospital “Agios Panteleimon”, Athens, Greece. Funding sources: Attikon Hospital was the research sponsor (Clinicaltrials.gov identifier: NCT01138852). Declarations of interest: authors reported that had no competing interests. Additional information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Using a random‐number generator”. |
Allocation concealment (selection bias) | Low risk | Quote: “The sequence was obtained using a central telephone number and it was concealed until interventions were assigned.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Participants ... were blinded to the intervention, however the physician administering the intervention and assessing the outcomes was not.” |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: “Participants ... were blinded to the intervention, however the physician administering the intervention and assessing the outcomes was not.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up were reported |
Selective reporting (reporting bias) | Unclear risk | Methods section indicates the primary outcomes will be postoperative infections at surgical site and elsewhere, so it is not clear about specific outcomes to be measured. We did not assess the trial protocol and the trial registration form does not report outcomes to be collected. |
Other bias | Unclear risk | Not known. Authors reported that had no competing interests. |
BMI: body mass index BP: blood pressure CI: confidence interval CS: caesarean section Hb: haemoglobin IM: intramuscular IQR: interquartile range ITT: inetntion‐to‐treat IV: intravenous NaCl: sodium chloride PCV: packed cell volume PROM: premature rupture of membranes RCT: randomised controlled trial RR: risk ratio sg: subgroup UTI: urinary tract infection vs: versus
P. Penicillins
P1. Natural penicillins P2. Broad spectrum penicillins
P2+. Broad spectrum penicillins plus betalactamase inhibitors. P3. Antistaphylococcal penicillins
C. Cephalosporins
C1. First‐generation cephalosporins C2. Second‐generation cephalosporins C3. Third‐generation cephalosporins C4. Fourth‐generation cephalosporins
F. Fluoroquinolones
T. Tetracyclines
M. Macrolides
Ca. Beta‐lactams/carbapenems
A. Aminoglycosides
L. Lincosamides
N. Nitroimidazoles