Abstract
BackgroundApproximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis.Methods/DesignWe are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ≥4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (<20 week) ultrasound. CHWs prospectively collect data on all pregnancy outcomes, maternal and neonatal morbidity and mortality.Implications/DiscussionFindings will enhance our understanding of the burden of AVF and UTI in rural Bangladesh, the impact of a maternal screening-treatment program for genitourinary tract infections on perinatal health, and help formulate public health recommendations for infection screening in pregnancy in low-resource settings.Trial registrationThe study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156.
Highlights
Half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings
Maternal genitourinary tract infections have been significantly associated with a wide range of adverse perinatal and maternal outcomes, including miscarriage, stillbirth, preterm birth, fetal growth restriction, neonatal and puerperal sepsis, neonatal encephalopathy and neonatal and maternal mortality [13,14,15,16]
The Projahnmo Maternal Infection Screening and Treatment (MIST) Study, expected to be completed at the end of 2015, is a cluster randomized trial that will evaluate the impact of an early pregnancy screening and treatment program for Abnormal vaginal flora (AVF) and Urinary tract infection (UTI) on population-level rates of preterm birth, compared to a basic package of routine antenatal and postpartum care alone
Summary
Half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. We will assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis. Maternal genitourinary tract infections have been significantly associated with a wide range of adverse perinatal and maternal outcomes, including miscarriage, stillbirth, preterm birth, fetal growth restriction, neonatal and puerperal sepsis, neonatal encephalopathy and neonatal and maternal mortality [13,14,15,16]. Lower genital tract infections may ascend the reproductive tract and seed the amniotic cavity, which can trigger an inflammatory cascade eventually resulting in a number of adverse outcomes including preterm birth, chorioamnionitis, fetal growth restriction, stillbirth, puerperal sepsis and early onset sepsis. Maternal infection accounts for an estimated 50 % of preterm births [18], timely diagnosis and treatment of maternal infections is a prime target for the prevention of preterm birth, as well as other adverse pregnancy outcomes [19]
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