One-day compared with 7-day nitrofurantoin for asymptomatic bacteriuria in pregnancy: a randomized controlled trial.
OBJECTIVE
To evaluate whether a 1-day nitrofurantoin regimen is as effective as a 7-day regimen in eradicating asymptomatic bacteriuria during pregnancy.


METHODS
A multicenter, double-blind, randomized, placebo controlled noninferiority trial was conducted in antenatal clinics in Thailand, the Philippines, Vietnam, and Argentina. Pregnant women seeking antenatal care between March 2004 and March 2007 who met the inclusion and exclusion criteria were invited to participate in the study. Those who consented were randomly allocated to receive either a 1-day or a 7-day course of 100 mg capsules of nitrofurantoin, which was taken twice daily. The primary outcome was bacteriologic cure on day 14 of treatment.


RESULTS
: A total of 1,248 of 24,430 eligible women had asymptomatic bacteriuria, making the overall prevalence of 5.1%. Of these 1,248 women, 778 women were successfully recruited, and 386 and 392 women were randomly allocated to 1-day and 7-day regimens, respectively. Escherichia coli was the most common potentially pathogenic bacteria detected, its prevalence approaching 50%. Bacteriologic cure rates at treatment day 14 were 75.7% and 86.2% for 1-day and 7-day regimens, respectively. The cure rate difference was -10.5% (95% confidence interval -16.1% to -4.9%). Mean birth weight and mean gestational age at delivery were significantly lower in the 1-day regimen group. There were fewer adverse effects in the 1-day regimen group, but the differences were not statistically significant.


CONCLUSIONS
A 1-day regimen of nitrofurantoin is significantly less effective than a 7-day regimen. Women with asymptomatic bacteriuria in pregnancy should receive the standard 7-day regimen.


BACKGROUND
ISRCTN, isrctn.org, ISRCTN11966080


METHODS
I.
Lumbiganon
Pisake
P
Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. pisake@kku.ac.th
Villar
Jose
J
Laopaiboon
Malinee
M
Widmer
Mariana
M
Thinkhamrop
Jadsada
J
Carroli
Guillermo
G
Duc Vy
Nguyen
N
Mignini
Luciano
L
Festin
Mario
M
Prasertcharoensuk
Witoon
W
Limpongsanurak
Sompop
S
Liabsuetrakul
Tippawan
T
Sirivatanapa
Pannee
P
D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001437:Bacteriuria / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D009582:Nitrofurantoin / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D047928:Premature Birth; D011295:Prenatal Care; D011297:Prenatal Exposure Delayed Effects; D014944:World Health Organization; D055815:Young Adult
D000900:Anti-Bacterial Agents; D009582:Nitrofurantoin