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

Gidiri 2014.

Methods RCT. 2‐arm parallel study. Women randomised individually.
Participants Inclusion criteria
  • Women undergoing CS, elective and emergency.

  • N = 280.


Exclusion criteria
Women who declined to participate in the study; severe immunosuppression of any cause; stage 3 and 4 HIV infection; prolonged rupture of membranes more than 12 hours; surgery longer than 3 hours; chorioamnionitis diagnosed preoperatively and obvious concurrent infection that requires therapeutic antibiotics.
Interventions Intervention: Cephalosporin (B3) and metronidazole (I) combination.
  • Single dose of ceftriaxone 1 g IV plus metronidazole 500 mg IV preoperatively and no further antibiotics postoperatively, except for treatment of infection.

  • Total number randomised: N = 136 randomised, analysis on 112.


Comparison: Penicillin (A1) + chloramphenicol + amoxicillin (A4) + metronidazole (I) combination.
  • Antibiotics for 1 week as follows: preoperatively benzyl penicillin 5 MU IV and chloramphenicol 1g IV Postoperatively within 24 hours of the operation: IV benzyl penicillin 2.5 MU 6‐hourly for three doses and IV chloramphenicol 500 mg 6‐hourly for three doses. From day 1 postoperatively, amoxicillin 500mg t.d.s. for 7 days, metronidazole 400mg t.d.s. for 7 days.

  • Total number randomised: N = 144, analysis on 120.

Outcomes Pyrexia; admission with puerperal sepsis; wound sepsis; death; duration of hospital stay; laparotomy for pelvic abscess.
Notes Dates: 2 February 2012 to 30 May 2012.
Setting: Parirenyatwa and Harare (tertiary) hospitals, Zimbabwe.
Subgroups
  1. Mixed, elective and emergency CS.

  2. Cephalosporin given before cord clamping vs penicillin given both before and after cord clamping.

  3. Systemic ‐ IV.

  4. Single dose vs multiple doses.

  • Comparisons 1 (subgroup 4); 2; 3; 4.

  • Authors report 'No conflict of interest' and they alone are responsible for the content and writing of the paper. So appears to have no drug company involvement.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided.
Allocation concealment (selection bias) Low risk Randomisation was by taking a ticket from a box. There was an A4 envelope of tickets at each of the two maternity units. Each envelope contained 75 tickets marked Arm 1 and 75 marked Arm 2. The ticket for Arm 1 was identical to that of Arm 2 in size, shape and material.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not really possible to blind as one group had a single dose and the other had a weeks prescription.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information so most likely assessors were not blinded either.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Women lost to follow‐up were 24 in each group.
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Unclear risk Baseline data showed no imbalance on: age; marital status; education; occupation; booking status; HIV. Otherwise unclear. Authors report 'No conflict of interest' and they alone are responsible for the content and writing of the paper. So appears to have no drug company involvement.