TY - JOUR
AU - A. Baewert
AU - R. Jagsch
AU - B. Winklbaur
AU - G. Kaiser
AU - K. Thau
AU - A. Unger
AU - C. Aschauer
AU - M. Weninger
AU - V. Metz
A1 - 
AB - 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. Conclusion: 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.
BT - European addiction research
C5 - Opioids & Substance Use; Healthcare Disparities
CP - 3
DO - 10.1159/000335082
IS - 3
JF - European addiction research
N2 - 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. Conclusion: 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.
PY - 2012
SN - 1022-6877; 1421-9891
SP - 130
EP - 139
EP - 
T1 - Influence of Site Differences between Urban and Rural American and Central European Opioid-Dependent Pregnant Women and Neonatal Outcome Characteristics
T2 - European addiction research
TI - Influence of Site Differences between Urban and Rural American and Central European Opioid-Dependent Pregnant Women and Neonatal Outcome Characteristics
U1 - Opioids & Substance Use; Healthcare Disparities
U2 - 22354163
U3 - 10.1159/000335082
VL - 18
VO - 1022-6877; 1421-9891
Y1 - 2012
ER -