title: Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.
abstract: BACKGROUND
  To evaluate a delivery strategy for newborn interventions in rural Bangladesh.
  
  
  METHODS
  A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.
  
  
  RESULTS
  A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.
  
  
  CONCLUSIONS
  Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00198627.
authors.affiliation: Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America. gary.darmstadt@gatesfoundation.org
authors.forename: Gary L
authors.initials: GL
authors.lastname: Darmstadt
authors.forename: Yoonjoung
authors.initials: Y
authors.lastname: Choi
authors.forename: Shams E
authors.initials: SE
authors.lastname: Arifeen
authors.forename: Sanwarul
authors.initials: S
authors.lastname: Bari
authors.forename: Syed M
authors.initials: SM
authors.lastname: Rahman
authors.forename: Ishtiaq
authors.initials: I
authors.lastname: Mannan
authors.forename: Habibur Rahman
authors.initials: HR
authors.lastname: Seraji
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Winch
authors.forename: Samir K
authors.initials: SK
authors.lastname: Saha
authors.forename: A S M Nawshad Uddin
authors.initials: AS
authors.lastname: Ahmed
authors.forename: Saifuddin
authors.initials: S
authors.lastname: Ahmed
authors.forename: Nazma
authors.initials: N
authors.lastname: Begum
authors.forename: Anne C C
authors.initials: AC
authors.lastname: Lee
authors.forename: Robert E
authors.initials: RE
authors.lastname: Black
authors.forename: Mathuram
authors.initials: M
authors.lastname: Santosham
authors.forename: Derrick
authors.initials: D
authors.lastname: Crook
authors.forename: Abdullah H
authors.initials: AH
authors.lastname: Baqui
mesh_terms: D000022:Abortion, Spontaneous; D001459:Bangladesh; D003153:Community Health Services / Q000458:organization & administration; D005260:Female; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods / Q000458:organization & administration*; D011785:Quality Assurance, Health Care; D012307:Risk Factors; D019035:Rural Health Services / Q000458:organization & administration*; D012424:Rural Population; D050497:Stillbirth