| Methods |
Randomised, double‐blind, placebo‐controlled trial. |
| Participants |
400 pregnant women during GA 28 to 32 wks.
(Unselected pregnant women.) |
| Interventions |
Single dose of 250 mg ceftriaxone IM versus placebo 3.5 mL 0.9% NaCl IM. |
| Outcomes |
Mean birthweight in the ceftriaxone group 153 g higher than in the placebo group, i.e. 3209 versus 3056 (P = 0.01). |
| Notes |
Nairobi, Kenya.
60% of the treatment group and 57% of the placebo group were delivered at the study centre; the rest were delivered elsewhere. 166 participants were lost to follow‐up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Patients were randomised by means of sealed envelopes into treatment and control groups. |
| Allocation concealment (selection bias) |
Low risk |
Patients were randomised by means of sealed envelopes into treatment and control groups. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not mentioned in the trial report. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not mentioned in the trial report. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Of the 400 participants, 60% of the treatment group and 57% of the placebo group delivered at the study centre; the rest delivered elsewhere. 166 participants were lost to follow‐up. |
| Selective reporting (reporting bias) |
Unclear risk |
Unknown. |
| Other bias |
Low risk |
None. |
