title: Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial.
abstract: BACKGROUND
  Approximately 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
  We 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.
  Findings 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.
  
  
  BACKGROUND
  The study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156 .
authors.affiliation: Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA.|Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Anne C C
authors.initials: AC
authors.lastname: Lee
authors.affiliation: International Centre for Diarrheal Diseases- Bangladesh, Centre for Reproductive Health, Mohakhali, Dhaka, 1212, Bangladesh.
authors.forename: Mohammad A
authors.initials: MA
authors.lastname: Quaiyum
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Luke C
authors.initials: LC
authors.lastname: Mullany
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Dipak K
authors.initials: DK
authors.lastname: Mitra
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Alain
authors.initials: A
authors.lastname: Labrique
authors.affiliation: International Centre for Diarrheal Diseases- Bangladesh, Centre for Reproductive Health, Mohakhali, Dhaka, 1212, Bangladesh.
authors.forename: Parvez
authors.initials: P
authors.lastname: Ahmed
authors.affiliation: Department of Microbiology, Child Health Research Foundation, Dhaka Shishu Hospital, Sher-E-Banglanagar, Dhaka, 1207, Bangladesh.
authors.forename: Jamal
authors.initials: J
authors.lastname: Uddin
authors.affiliation: Department of Microbiology, Child Health Research Foundation, Dhaka Shishu Hospital, Sher-E-Banglanagar, Dhaka, 1207, Bangladesh.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Rafiqullah
authors.affiliation: International Centre for Diarrheal Diseases- Bangladesh, Centre for Reproductive Health, Mohakhali, Dhaka, 1212, Bangladesh.
authors.forename: Sushil
authors.initials: S
authors.lastname: DasGupta
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Arif
authors.initials: A
authors.lastname: Mahmud
authors.affiliation: Center for Disease Control, 1600 Clifton Road, Atlanta, GA, 30329, USA.
authors.forename: Emilia H
authors.initials: EH
authors.lastname: Koumans
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Parul
authors.initials: P
authors.lastname: Christian
authors.affiliation: Department of Microbiology, Child Health Research Foundation, Dhaka Shishu Hospital, Sher-E-Banglanagar, Dhaka, 1207, Bangladesh.
authors.forename: Samir
authors.initials: S
authors.lastname: Saha
authors.affiliation: Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA. abaqui@jhu.edu.
authors.forename: Abdullah H
authors.initials: AH
authors.lastname: Baqui
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000892:Anti-Infective Agents, Urinary / Q000627:therapeutic use; D001459:Bangladesh; D002981:Clindamycin / Q000627:therapeutic use; D016000:Cluster Analysis; D003150:Community Health Workers; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009582:Nitrofurantoin / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000517:prevention & control*; D011295:Prenatal Care / Q000379:methods*; D012424:Rural Population; D014552:Urinary Tract Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D059349:Urine Specimen Collection / Q000379:methods; D014621:Vagina / Q000382:microbiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000892:Anti-Infective Agents, Urinary; D002981:Clindamycin; D009582:Nitrofurantoin