title: Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics.
abstract: BACKGROUND
  Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors.
  
  
  METHODS
  Site differences of a multi-center prospective double-blind, double-dummy randomized controlled trial (7 centers: Central Europe (Vienna)/USA (3 urban/3 rural centers)) comparing safety and efficacy of methadone and buprenorphine in pregnant opioid-dependent women and their neonates.
  
  
  RESULTS
  Urban US women had the highest rate of concomitant opioid (p = 0.050) and cocaine consumption (p = 0.003), the highest dropout rate (p = 0.001), and received the lowest voucher sums (p = 0.001). Viennese neonates had significantly higher Apgar scores 1 min (p = 0.001) and 5 min after birth (p < 0.001) and were more often born by cesarean section (p = 0.024). Rural US newborns had a significantly shorter neonatal abstinence syndrome treatment duration compared to Viennese and urban US sites (p = 0.006), in addition to other site-specific differences, suggesting a more severely affected group of women in the urban US sites.
  
  
  CONCLUSIONS
  This clinical trial represents a role model for pharmacological treatment in this unique sample of pregnant women and demonstrates the clinical importance of considering site-specific factors in research and clinical practice.
authors.affiliation: Department of Psychiatry and Psychotherapy, Medical University Vienna, Vienna, Austria.
authors.forename: Andjela
authors.initials: A
authors.lastname: Baewert
authors.forename: Reinhold
authors.initials: R
authors.lastname: Jagsch
authors.forename: Bernadette
authors.initials: B
authors.lastname: Winklbaur
authors.forename: Gerda
authors.initials: G
authors.lastname: Kaiser
authors.forename: Kenneth
authors.initials: K
authors.lastname: Thau
authors.forename: Annemarie
authors.initials: A
authors.lastname: Unger
authors.forename: Constantin
authors.initials: C
authors.lastname: Aschauer
authors.forename: Manfred
authors.initials: M
authors.lastname: Weninger
authors.forename: Verena
authors.initials: V
authors.lastname: Metz
mesh_terms: D000293:Adolescent; D000328:Adult; D002047:Buprenorphine / Q000627:therapeutic use; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008691:Methadone / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D011256:Pregnancy Outcome / Q000453:epidemiology / Q000523:psychology; D037841:Pregnant People / Q000523:psychology; D011446:Prospective Studies; D012424:Rural Population; D014481:United States / Q000453:epidemiology; D014505:Urban Population; D055815:Young Adult
chemical_list: D002047:Buprenorphine; D008691:Methadone