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 |
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Interventions | Sulfadimethoxine 500 mg daily; sulphadiazine 1 g, 3 times a day after 36 weeks vs placebo Treatment continued until delivery |
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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 |
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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 |
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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 |