Randomized controlled trials in pregnancy: scientific and ethical aspects. Exposure to different opioid medications during pregnancy in an intra-individual comparison

Autor:	Berndadette Winklbaur, Andjela Bäwert, Harald Leitich, Reinhold Jagsch, Constantin Aschauer, Klaudia Rohrmeister, Hendrée E. Jones, Gabriele Fischer, Annemarie Unger, Amelia M. Arria
Rok vydání:	2011
Předmět:	medicine.medical_specialty Pregnancy business.industry Medicine (miscellaneous) Opiate Substitution Treatment medicine.disease law.invention Clinical trial Psychiatry and Mental health Opioid Randomized controlled trial law Severity of illness Emergency medicine medicine Psychiatry business Buprenorphine medicine.drug Methadone
Zdroj:	Addiction. 106:1355-1362
ISSN:	0965-2140
DOI:	10.1111/j.1360-0443.2011.03440.x
Popis:	Background Chronic medical conditions such as opioid dependence require evidence-based treatment recommendations. However, pregnant women are underrepresented in clinical trials. We describe the first within-subject comparison of maternal and neonatal outcomes for methadone vs. buprenorphine exposed pregnancies. Though methadone is the established treatment of pregnant opioid dependent women, recent investigations have shown a trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of maintenance medication that determines the occurrence of NAS, other factors such as maternal metabolism, illicit substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors in the assessment of randomized clinical trials.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::6de82fd46f6de92bb54cf173215a36bc https://doi.org/10.1111/j.1360-0443.2011.03440.x Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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