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. 2014 Nov 17;2014(11):CD008726. doi: 10.1002/14651858.CD008726.pub2

Ziogos 2010.

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: cephalosporin (B2).
  • Cefuroxime (1.5 g).

  • IV.

  • After the time the umbilical cord was clamped.

  • Total number randomised: n = 85.


Comparison: penicillin (A4) combination.
  • Ampicillin/sulbactam 3 g.

  • IV.

  • after the time the umbilical cord was clamped.

  • Total number randomised: n = 91.

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 post‐operatively 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.
Subgroups
  1. Mixed elective and emergency CS.

  2. After cord clamping.

  3. Systemic ‐ IV.

  4. Single dose.

  • Comparison: 1 (subgroup 2); 2; 3; 4; 8.

  • Authors reported that had no competing interests.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “Using a random‐number generator”.
Allocation concealment (selection bias) Low risk “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 “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 “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 loss of follow‐up were reported
Selective reporting (reporting bias) Unclear risk The study protocol is unavailable.
Other bias Unclear risk Not known. Authors reported that had no competing interests.

BP: blood pressure
 CI: confidence interval
 CS: caesarean section
 Hb: haemoglobin
 IM: intramuscular
 IV: intravenous
 PROM: premature rupture of membranes
 RCT: randomised controlled trial
 RR: risk ratio
 t.d.s.: three times daily
 UTI: urinary tract infection
 vs: versus

A. Penicillins

A1. Natural penicillins
 A2. Penicillinase‐resistant penicillins
 A3. Extended‐spectrum penicillins
 A4. Aminopenicillins

B. Cephalosporins

B1. First generation cephalosporins
 B2. Second generation cephalosporins
 B3. Third generation cephalosporins
 B4. Fourth generation cephalosporins

C. Fluoroquinolones

D. Tetracyclines 

E. Macrolides 

F. Beta‐lactams/carbapenems 

G. Aminoglycosides

H. Lincosamides 

I. Nitroimidazoles