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

Gold 1966.

Methods Placebo‐controlled, randomised trial; 2 parallel groups. Quasi‐RCT
Participants Inclusion criteria: bacteriuria (> 100,000 bacteria/mL x 2: midstream urine) at any prenatal visit
Setting: New York, NY (85% non‐white)
Number of participants: N = 65
Interventions Sulfadimethoxine 500 mg daily; sulphadiazine 1 g, 3 times a day after 36 weeks vs placebo
Treatment continued until delivery
Outcomes Persistent bacteriuria at delivery
Pyelonephritis
Preterm birth (not defined further): treatment group 2/35; placebo 0/30
No infants developed jaundice; no toxic manifestations in women in treatment group
Notes Only antepartum episodes of pyelonephritis included in analysis. There were 2 postpartum episodes of pyelonephritis in the placebo group, none in treatment group.
Dates of study: February 1962 to December 1964
Funding sources: Health Research Council of the City of New York (U‐1177); in‐kind support (antibiotic and placebo tablets) Hoffman‐La Roche Inc. Nutley, NJ
Declarations of interest: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Women allocated to treatment based on study number: odd number treatment, even number control
Allocation concealment (selection bias) High risk Allocated to treatment based on study number
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Placebo‐controlled; no further details provided
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk It does not appear that there was any loss to follow‐up.
Selective reporting (reporting bias) High risk No definition provided for prematurity.
Other bias Low risk The study appears to be free of other sources of bias.
Overall Risk of Bias Unclear risk Overall unclear