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. 2021 Mar 4;2021(3):CD008726. doi: 10.1002/14651858.CD008726.pub3

Ziogos 2010.

Study characteristics
Methods Prospective RCT ‐ 2 parallel arms ‐ women randomised individually.
Participants Inclusion criteria
  • Women undergoing CS.

  • N = 176.


Exclusion criteria
  • Women with known hypersensitivity to penicillin, cephalosporins, those who required concomitant antibiotic therapy or had received antibiotics during the 72 hours immediately preceding their enrolment.

Interventions Intervention: 2nd generation cephalosporin (C2)
  • Cefuroxime (C2) (1.5 g).

  • IV.

  • Single dose after the time the umbilical cord was clamped.

  • Total number randomised: n = 85.


Comparator: broad spectrum penicillin plus betalactamase inhibitor (P2+)
  • Ampicillin/sulbactam (P2+) 3 g.

  • IV.

  • Single dose after the time the umbilical cord was clamped.

  • Total number randomised: n = 91.


Subgroups
  • Type of CS: both elective and non‐elective (subgroup 3)

  • Generation of cephalosporin: 2nd generation cephalosporin, C2 (subgroup 2)


Comparisons: 1; 2 (subgroup 3); 3 (subgroup 2)
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.
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
  • Costs: the authors reported information on the cost of each drug that is reported narratively in our results. Quote: “The ampicillin‐sulbactam regimen used in our study costs 5,07 Euros per patient in our country and was more costly than the cefuroxime regimen that costs 2,38 Euros per patient.”

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