PROJECT SUMMARY/ABSTRACT
Asymptomatic bacteriuria (AB) in pregnancy has been associated with an increased incidence of neonatal
morbidity including preterm birth and low birth weight (LBW) and maternal morbidity including pyelonephritis.
Hypothesis: Treatment of pregnant individuals with AB will reduce the incidence of newborns with LBW in
low- and middle-income countries (LMICs).
Significance: LBW occurs in more than 20 million newborns each year globally and is associated with an
increased risk of neonatal death and lifetime morbidity. This proposal will examine the impact of treating AB
in pregnant individuals in LMICs on the incidence of LBW and serious maternal and neonatal morbidity.
Investigators: Dr. Chisholm (mPI) is an academic maternal-fetal medicine subspecialist with 5 years of
experience as a member of the NICHD Global Network for Women’s and Children’s Health Research (GN)
and investigator in global clinical trials. Dr. McClure (mPI) is a perinatal epidemiologist and PI of the Data
Coordinating Center who has more than 20 years of experience contributing to the leadership of the GN and
overseeing research in LMICs. Co-Is Dr. Petri at the University of Virginia and Dr. Haque at the International
Centre for Diarrheal Disease Research, Bangladesh, have collaborated for 30 years on maternal–child
health and infectious diseases research.
Innovation: The proposed study will address calls from the World Health Organization, USPSTF, and
numerous professional societies for data evaluating the impact of treatment for AB in contemporary obstetric
populations in LMICs where the burden of LBW and associated neonatal morbidity is highest and where the
practice of screening for AB is less widely implemented.
Approach: We will conduct a randomized, double-blind, placebo-controlled parallel-arm trial to address the
following specific aims:
Specific Aim 1: Test the primary outcome of the trial, which is the impact of antibiotic (nitrofurantoin)
treatment of AB on LBW. This will be done by comparing the incidence of LBW between those randomized
to receive nitrofurantoin and those randomized to receive placebo.
Specific Aim 2: Test the secondary outcome of the trial, which is the impact of antibiotic treatment of AB on
serious maternal morbidity in pregnancy. This will be done by comparing maternal morbidity between those
randomized to receive nitrofurantoin and those randomized to receive placebo. We hypothesize that
treatment of AB in pregnancy will reduce the incidence of pyelonephritis and pre-eclampsia.
