Elder 1966.
| Methods | Placebo‐controlled; 2 parallel groups | |
| Participants | Inclusion criteria: bacteriuria (same bacterial species in first 3 uncontaminated clean‐voided urine specimens, with 2 samples > 100,000 bacteria/mL and 1 sample > 10,000 bacteria/mL) Exclusion criteria: > 32 weeks' gestation Setting: Boston City Hospital, USA |
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| Interventions | Sulfasymazine 0.5 g daily until delivery (N = 54) or placebo (N = 52) | |
| Outcomes | Persistent bacteriuria, after 3 weeks of treatment (13/52 treatment vs 48/50 in placebo group) and at last clinic visit before delivery (12/52 vs 30/49) | |
| Notes | 2 women were lost to follow‐up in the treatment group and 3 women lost to follow‐up in the placebo group and have not been included in the analysis 7/52 women in the placebo group developed asymptomatic pyelonephritis (not further defined and not included as an outcome) 1 adverse event reported in treatment group (vomiting); no rash, pruritus or photosensitivity; no newborn kernicterus diagnosed Dates of study: June 1965 to March 1966 Funding sources: Public Health Service grants HD‐01288 from the National Institutes of Health, and FR‐76 from the Division of Research Facilities and Resources, National Institutes of Health. 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 | "... a random sequence"; insufficient information provided to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | No information provided to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "... double‐blind trial"; no information provided to permit judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "... double‐blind trial"; no information provided to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Information provided on women lost to follow‐up, reasonably balanced between groups |
| Selective reporting (reporting bias) | High risk | Results not provided for outcome of pyelonephritis for all participants; no pregnancy outcomes (gestational age, birthweight) |
| Other bias | Low risk | The study appears to be free of other sources of bias. |
| Overall Risk of Bias | Unclear risk | Unclear overall |