Furness 1975.
Methods | Randomised trial, 3 parallel groups | |
Participants | Inclusion: bacteriuric (> 100,000 bacteria/mL x 1 or > 10,000 bacteria/mL x 2; midstream urine) at second antenatal visit Setting: South Australia Enrollment period: not stated Number of participants: N = 206 | |
Interventions | Methenamine mandelate or methenamine hippurate 1 g, 4 times a day vs no treatment Treatment continued until delivery | |
Outcomes | Pyelonephritis (frequency and burning on micturition, pyrexia, or loin tenderness and significant bacteriuria) Preterm birth (defined as less than or equal to 38 weeks' gestation); treatment 24/139 (17%) vs control 10/67 (15%) Mean birthweight: methenamine hippurate 3273 g SE ± 70.7; methenamine mandelate 3303 SE ± 68.2; control 3353 g SE ± 73.9; no difference Postnatal bacteriuria at 6 weeks: 26/73 treatment vs 10/27 no treatment |
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Notes | Women randomised to either methenamine mandelate (N = 69), methenamine hippurate (N = 70), or no treatment (N = 67); for analyses, treatment groups combined. Unable to separate incidence of pyelonephritis during pregnancy and puerperium; results combined. Dates of study: 1971 to 1972 (estimated) Funding sources: Queen Victoria Research Foundation, South Australia 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 | " by random allocation"; no additional details 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 | High risk | Not placebo‐controlled. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided to permit judgement. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20/226 women withdrawn from trial; no details provided. All women included in outcome of pyelonephritis; 17% loss to follow‐up for outcome of low birthweight and gestational age at delivery. |
Selective reporting (reporting bias) | High risk | Unable to separate incidence of pyelonephritis during pregnancy and puerperium; results combined. |
Other bias | Low risk | The study appears to be free of other sources of bias. |
Overall Risk of Bias | High risk | Judged at overall high risk of bias. |