| Methods |
Randomized controlled trial. No description of method for generation and concealment of treatment. Providers and pregnant women were not blinded. It was unclear whether the following criteria were met: blinding of outcome assessment, measurement of contamination of control group, assessment of co‐interventions, any deviation from protocol. Informed consent was obtained. No description of sample size or power calculation. |
| Participants |
41 women enrolled in study. Setting: out‐patient clinic in Denmark. Inclusion criteria: pregnant women < 36 weeks estimated gestational age; confirmed asymptomatic bacteriuria with 2 consecutive urine cultures of bacterial count ≧ 100,000 colonies/mL urine; urine culture was sensitive to sulfamethizole. Exclusion criteria: signs of urinary tract infection; chronic disease of the genitourinary tract; history of more than 2 urinary tract infections in previous 12 months; threatening preterm labour > 26 weeks estimated gestational age; allergy to sulfonamides; antibiotic therapy for any reason within 3 weeks prior to study. |
| Interventions |
Experimental group: sulfamethizole 2 g x single dose.
Control group: sulfamethizole 1 g twice daily x 6 days. |
| Outcomes |
Clinical outcomes: medication side effects.
Laboratory outcomes: 'no cure', recurrence of asymptomatic bacteriuria. |
| Notes |
Type of healthcare provider: not described.
Attrition bias: no women lost from experimental group 0/15; 2/26 (8%) women lost to follow‐up from control group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not mentioned. |
| Allocation concealment (selection bias) |
Unclear risk |
Not mentioned. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
2 dropouts in the longer treatment arm. |
| Selective reporting (reporting bias) |
Unclear risk |
Not mentioned. |
| Other bias |
Unclear risk |
Lack of information in text to assess other sources of bias. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not mentioned. |
