Lenke 1983.
Methods | RCT. | |
Participants | Number of pregnant women randomised: 200. Inclusion criteria
Exclusion criteria
Setting: Los Angeles, USA. Period: October 1979 ‐ May 1981. Definitions
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Interventions |
Intervention group (n = 100): Nitrofurantoin 50 mg orally, 3 times daily, for the remainder of the pregnancy plus close surveillance. Control group (n = 100): close surveillance only. ALL WOMEN Follow‐up (close surveillance): all patients were followed in the special clinic every 2 weeks until the 36 weeks when they were seen weekly until delivery. At each visit a clean‐catch, mid voided urine was obtained for a routine culture and nitrite testing. When culture results were positive, attempts were made to reach patients to schedule a return appointment within 1 week. Treatment: irrespective of group, patients received a short course of antibiotics in clinic under 3 circumstances:
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Outcomes | Maternal
Infants
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random number tables." |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participant: no blinding. Clinician: no blinding. Describe: “the control group received no pills” “ the doctors responsible for patient care were aware of whether the patient was in the treated or control group”. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Low for culture results. Low for pregnancy outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Lost to follow‐up:
No reasons given. |
Selective reporting (reporting bias) | High risk | Overall, very few pregnancy outcomes were measured. "observation period ended at the time of delivery, as logistics prevented longer follow‐up". |
Other bias | Low risk | No major baseline differences. |
CVA: costovertebral angle mL: millilitre RCT: randomised controlled trials UTI: urinary tract infection