Little 1966.
Methods | Placebo‐controlled, randomised; 2 parallel groups | |
Participants | Inclusion criteria: bacteriuria (> 100,000 bacteria/mL x 2, midstream urine) at first prenatal visit Setting: London, England Number of participants: N = 265 |
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Interventions | Sulphamethoxypyridazine 500 mg or (later) nitrofurantoin 100 mg daily continued until 6 weeks after delivery; ampicillin or nitrofurantoin were alternatives for failures (N = 124) or placebo (N = 141) | |
Outcomes | Pyelonephritis (loin pain and tenderness, fever and > 100,000 bacteria/mL) Low birthweight (< 2500 g) |
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Notes | Dates of study: 1962 to 1965 Funding sources: Dan Mason Research Foundation of the West London Medical Trust; Smith Kline and French Laboratories, Eaton Laboratories, Park Davis and Co, Beecham Research Laboratories, Cerebos Ltd and the Ockley Brick Works Declarations of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided about sequence generation to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Allocation to treatment or control was drawn from "a pool of sealed envelopes containing a slip of paper", but there was no information provided to ensure appropriate safeguards to prevent investigators being aware of treatment group. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Women in the control group "were given placebo"; no further details provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided to judge whether outcome assessment was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to judge |
Other bias | Low risk | The study appears to be free of other sources of bias. |
Overall Risk of Bias | Unclear risk | Overall unclear |