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STUDY DESIGN
Design:
randomised controlled trial.
Allocation:
concealed.*
Blinding:
blinded (patients, healthcare providers, data collectors, and outcome assessors).*
STUDY QUESTION
Setting:
antenatal clinics in 7 hospitals in Thailand, the Philippines, Vietnam, and Argentina.
Patients:
778 pregnant women (mean age 27 y) at 12–32 weeks of gestation who were diagnosed (by a 2-step screening process) as having asymptomatic bacteriuria caused by a micro-organism sensitive to nitrofurantoin. Women with symptoms of urinary tract infection (UTI), treatment of UTI in the current pregnancy, a condition requiring continuous steroid or antibiotic therapy, antibiotic hypersensitivity, or haematological disease (including glucose-6-phosphate dehydrogenase deficiency) were excluded.
Intervention:
nitrofurantoin, 100 mg orally twice daily, for 1 day (n = 386) or 7 days (n = 392). The 1-day group received placebo tablets after day 1 to …
Footnotes
Sources of funding: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development, and Research Training in Human Reproduction; Orion Diagnostica provided dipslides and Mepha Ltd provided study drugs.