Pathak 1969.
Methods | Placebo‐controlled; 2 parallel groups | |
Participants | Inclusion: bacteriuria (> 100,000 bacteria/mL x 2) Exclusion: > 24 weeks' gestation; BP > 130/90 mmHg Setting: Kingston, Jamaica |
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Interventions | Nitrofurantoin 100 mg twice a day x 3 weeks; 400 mg in 4 doses for further 4 days for those who did not respond (6 women), (N = 76) vs identical appearing placebo (N = 76) | |
Outcomes | Persistence of bacteriuria (at end of pregnancy); pyelonephritis (criteria not described) Postpartum bacteriuria (3 to 9 months): 6/24 treatment vs 16/45 placebo |
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Notes | 12/88 women in treatment group and 14/90 in control group not included in analysis (treated for positive treponemal serology N = 21; defaulted from clinic N = 5) Rates for preterm birth/fetal loss only presented by bacteriuric status, not treatment group Rates for postpartum bacteriuria available for 69 women Dates of study: not stated Funding sources: Norwich Pharmacal Company, Norwich, New York; National Institutes of Health, U.S. Public Health service (R 01‐HD 02139‐05) 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 | "on a random basis". Insufficient information provided to permit further judgement. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided to permit judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided to permit judgement. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced; reasons similar and unlikely to have introduced bias. |
Selective reporting (reporting bias) | High risk | 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 |