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. 2019 Nov 25;2019(11):CD000490. doi: 10.1002/14651858.CD000490.pub4

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
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)
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
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