Maternal genitourinary infections and adverse perinatal outcomes
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Maternal genitourinary (GU) infections, particularly bacterial vaginosis (BV) and urinary tract infections (UTI) are common but inadequately quantified in low-middle income countries. Preterm birth and infections account for majority (60%) of the estimated 4 million annual global neonatal deaths. About half of preterm births and the majority of early onset neonatal sepsis are attributed to maternal GU infections. The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora (BV with Nugent score >7 and intermediate flora with Nugent score 4-6) and UTI in early pregnancy (12-16 weeks) on preterm live birth in Sylhet District, Bangladesh. Secondary aims include evaluation of the program impact on the: a) proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and live birth) and b) proportion of newborns with early onset sepsis (Aim 2); determination of the prevalence of abnormal vaginal flora and UTI, including asymptomatic bactiuria, among pregnant rural Bangladeshi women (Aim 3); and evaluation of the accuracy of simple, low-cost, point of care diagnostic tests by community health workers (Aim 4). We will conduct a cluster randomized, controlled trial enrolling 12,698 pregnant mothers from rural Sylhet, Bangladesh. Community health workers (CHWs) (n=32), one for approximately 120 pregnant women/year, will be randomized either to provide the intervention or standard antenatal and postnatal care. For all women enrolled in the study, CHWs will conduct 2 antenatal and 4 postnatal home visits to provide counseling and selected services, and refer mothers or newborns with symptoms of serious illness to the sub-district hospital. In the intervention clusters, mothers will be screened for GU infections between 12-16 weeks; those with abnormal vaginal flora (Nugent score >4) will be treated with oral clindamycin for 5 days, rescreened after 3 weeks, and those with persistent abnormal flora will be retreated with a second course of oral clindamycin. UTI (urine culture >105 single uropathogen) will be treated with oral cefixime for 3 days. Symptomatic mothers will be referred to the primary health center for further evaluation; however, those with symptoms of isolated lower urinary tract infection who are unable to comply with referral will be given the option of home treatment. CHWs will prospectively collect data on pregnancy outcomes and neonatal and maternal morbidity. Gestational age will be determined by maternal report of last menstrual period. The study will be powered to detect a 15% reduction in preterm birth at the population level with 80% power and 5% type I error, accounting for the cluster design and loss to follow up, and is estimated to require 4 years of field work. We will additionally conduct a sub-study (n=2049) to validate point of care tests for BV (BVBlue) and UTI (Uriscreen, Urine dipstick). Findings will enhance our understanding of the burden of abnormal vaginal flora and UTI, the impact of a screening-treatment program on perinatal outcomes, and help formulate public health recommendations for screening and treatment of maternal GU infections in low-resource settings.