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

Mivumbi 2014.

Methods A prospective, randomised, open‐label, single‐site study,with two parallel arms. Women randomised individually.
Participants Inclusion criteria
  • Women undergoing CS for any indication at a gestation of 37 weeks 0 days or more.

  • N = 132.


Exclusion criteria
  • Preoperative clinical diagnosis of chorioamnionitis, a fever of 38° or higher at any point during admission, prior antibiotic use within 2 weeks, known HIV‐positive status, known allergy to penicillin or cephalosporin, and insulin‐dependent diabetes.

Interventions Intervention: cephalosporin (B1).
  • Cefazolin 1 g.

  • Administered intravenously no more than 60 minutes prior to skin incision.

  • Single dose.

  • Postoperative antibiotics were administered only if there was a diagnosis of infection, and were not given routinely.

  • Total number randomised: N = 66.


Comparison (usual care): aminopenicillin (A4).
  • Ampicillin 2 g (usual care group).

  • Administered intravenously no more than 60 minutes prior to skin incision.

  • Single dose.

  • Postoperative antibiotics were administered only if there was a diagnosis of infection, and were not given routinely.

  • Total number randomised: N = 66.

Outcomes Outcomes: The primary outcome variable was postoperative febrile morbidity. Secondary outcomes were infection‐related complications defined as endometritis, wound infection, UTI, fever with unexplained source, need for therapeutic antibiotics, and length of postoperative days in hospital (starting the day after surgery and including the day of discharge).
Reported outcomes: Febrile morbidity, endometritis, wound infection, UTI, unexplained fever(febrile morbidity), required therapeutic antibiotics, length of postoperative stay, allergic reactions.
Notes Dates: March 1 to May 31, 2012.
Setting: The Centre Hospitalier Universitaire de Kigali/University Teaching Hospital of Kigali (CHUK), which is located in Kigali, the capital of Rwanda, is 1 of 3 tertiary care referral hospitals in the Rwandan healthcare system and, compared with district hospitals, receives a disproportionate number of women needing CS.
Subgroups
  1. Both elective and emergency CS.

  2. Before cord clamping.

  3. Systemic.

  4. Single dose.

  • Comparisons: 1 (subgroup 1); 2; 3; 4; 6.

  • Reported that authors have no conflict of interest. Funding source of study not reported.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The cards inside the envelopes were randomized by the principle investigator using a random integer generator."
Allocation concealment (selection bias) Low risk “The women were preoperatively randomized to 1 of 2 study groups via numerically ordered cards in sealed envelopes...The
allocated envelopes were opened by clinicians only after the decision for cesarean delivery was made."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk “...open‐label...”.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk As open‐label RCT the investigators were not blinded but the assessors could have been blinded. .
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "No women were lost to follow‐up”.
Selective reporting (reporting bias) Unclear risk The study protocol is not available.
Other bias Unclear risk Not known. Reported that authors have no conflict of interest. Funding source of study not reported.