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

Rudge 2006.

Study characteristics
Methods RCT. Individual women. 3‐arm study.
Participants Inclusion criteria
  • Women due for CS.

  • N = 600, however only 400 women included in this review (remaining 200 received no antibiotic prophylaxis)


Exclusion criteria
  • Urinary or pulmonary complications

  • Infections justifying use of antibiotics

  • Fever

  • Use of antimicrobial agents in past 15 days

  • Events requiring use of other antimicrobial agents before randomisation.

Interventions Intervention 1: 1st generation cephalosporin (C1)
  • Cephalothin

  • 2 g, IV, single intraoperative dose given soon after cord clamping·

  • Total number randomised: N = 200


Intervention 2: natural penicillins(standard at hospital).
  • Benzathine penicillin (P1) + procaine penicillin (P1)

  • Benzathine penicillin 1,200,000IU given IM + procaine penicillin 400,000 IU given IM given every 12 hours during 1st 48 hours

  • Unclear from trial report when first dose given, however report implies that this is standard scheme and that all drugs were given postoperatively. 

  • Total number randomised: N = 200


Comparator: no antibiotics ‐ data not used in this review
  • No antibiotics.

  • Total number randomised: N = 200


Subgroups
  • Type of CS: unclear

  • No primary outcome data for subgroup analyses


Comparisons: 4
Outcomes Puerperal infection; wound infection; post CS infection; costs of antibiotics.
Notes Dates of study: March 1994 to July 1996.
Setting: Unversity Teaching Hospital, Botucata School of Medicine, Sao Paulo State University, UNESP, Brazil. 1500 births annually.
Funding sources: not reported.
Declarations of interest: not reported.
Additional information
  • Costs: the authors provide brief information on cost of interventions which we report narratively in our results. "In Brazil a penicillin scheme costs US$ 1.17 per patient and a cephalothin US$ 1.0 per patient", The authors conclude that "prophylactic cephalothin use was associated with decreased puerperal infection and presented a cost benefit".

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer generated random numbers".
Allocation concealment (selection bias) Unclear risk Quote: "Sealed envelopes".
Blinding of participants and personnel (performance bias)
All outcomes High risk No information provided and routes of administration are different so likely the clinicians knew.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: “the outcome observers were not informed about which group the patients had been allocated to”
Incomplete outcome data (attrition bias)
All outcomes Low risk No loss to follow‐up.
Selective reporting (reporting bias) Unclear risk Pre‐specified outcomes only were reported but we did not assess trial protocol.
Other bias Unclear risk Baseline characteristics similar. ITT analysis. Too little methodological information to assess if other biases.