Mivumbi 2014.
Methods | A prospective, randomised, open‐label, single‐site study,with two parallel arms. Women randomised individually. | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: cephalosporin (B1).
Comparison (usual care): aminopenicillin (A4).
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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. |
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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
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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. |