Influence of site differences between urban and rural American and Central European opioid dependent pregnant women and neonatal characteristics
- Autor(en)
- Andjela Baewert, Reinhold Jagsch, Bernadette Winklbaur, Gerda Kaiser, Kenneth Thau, Annemarie Unger, Constantin Aschauer, Manfred Weninger, Verena Metz
- Abstrakt
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 multicenter
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.
- Organisation(en)
- Institut für Klinische und Gesundheitspsychologie
- Externe Organisation(en)
- Medizinische Universität Wien
- Journal
- European Addiction Research
- Band
- 18
- Seiten
- 130-139
- Anzahl der Seiten
- 10
- ISSN
- 1022-6877
- DOI
- https://doi.org/10.1159/000335082
- Publikationsdatum
- 2012
- Peer-reviewed
- Ja
- ÖFOS 2012
- 303029 Suchtforschung, 504007 Empirische Sozialforschung, 501010 Klinische Psychologie
- Schlagwörter
- Link zum Portal
- https://ucrisportal.univie.ac.at/de/publications/ee9b7df2-af9d-4edb-83c6-e16655457730