Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics.

European Addiction Research
Andjela BaewertVerena Metz

Abstract

Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors. 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. 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. 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 resear...Continue Reading

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Citations

Nov 20, 2012·Human Psychopharmacology·Bernadette Winklbaur-HausknostGabriele Fischer
Apr 29, 2014·Substance Abuse : Official Publication of the Association for Medical Education and Research in Substance Abuse·Verena E MetzGabriele Fischer
Sep 19, 2012·European Addiction Research·Robert G Newman, Susan G Gevertz
Jul 5, 2016·Substance Abuse : Research and Treatment·Naana Afua Jumah

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