A prospective randomized controlled trial to evaluate the impact of treatment of asymptomatic bacteriuria on low birth weight

Active Cooperative Agreement Awarded Last action

Award ID
U01HD115569
Recipient
Awarding agency
Obligated
$5,147,826

Award facts

Completion date 53% complete
Place of performance
North Carolina, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

Transactions

Action Obligated Date
Amendment $1,016,850
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $1,100,885
Amendment $1,100,885
Amendment $1,100,885
Amendment $0
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Original award $828,321
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Subawards

Subrecipient Amount Awarded
Rector & Visitors Of The University Of Virginia Subcontract 1-312-0219784 Initial Award $203,795

Quick answers

Who received award U01HD115569?

U01HD115569 was awarded to Research Triangle Institute by National Institute of Child Health and Human Development (National Institutes of Health) on September 20, 2024.

How much is award U01HD115569 worth?

$5,147,826 has been obligated on U01HD115569.

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