Gidiri 2014.
Methods | RCT. 2‐arm parallel study. Women randomised individually. | |
Participants |
Inclusion criteria
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. |
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Interventions |
Intervention: Cephalosporin (B3) and metronidazole (I) combination.
Comparison: Penicillin (A1) + chloramphenicol + amoxicillin (A4) + metronidazole (I) combination.
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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
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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. |