title: Impact of treatment approach on maternal and neonatal outcome in pregnant opioid-maintained women.
abstract: OBJECTIVE
  The objective of this study is to compare maternal and neonatal outcome of opioid-dependent women maintained on buprenorphine or methadone throughout pregnancy in a randomized double-blind double-dummy clinical trial (CT) with a comparison group undergoing a structured standard protocol (SP) at the Medical University of Vienna, Austria.
  
  
  METHODS
  One hundred and fourteen subjects were included in the analysis, with 77 in SP (n = 51 methadone, n = 26 buprenorphine), and 37 in CT (n = 19 methadone, n = 18 buprenorphine), comparing maternal concomitant consumption during third trimester, demographic birth data, duration of treatment for neonatal abstinence syndrome (NAS), morphine dose for NAS treatment and length of hospital stay (LOS).
  
  
  RESULTS
  Both study groups yielded healthy neonates with no significant demographic differences and equivalently low rates of positive maternal urine toxicologies. However, NAS parameters were significantly better in CT regarding total medication dose administered to neonates (p = 0.014) and LOS (p = 0.015). Superior results were achieved in buprenorphine compared with methadone-exposed neonates regarding gestational age at birth (p = 0.003), birth weight (p = 0.011), total morphine dose administered (p = 0.008), NAS treatment duration (p = 0.008) and LOS (p = 0.001).
  
  
  CONCLUSIONS
  Comparably favorable outcome for mothers and infants and efficacy and safety of opioid medications were shown in both treatment approaches. Neonatal care could benefit from transferring successful CT procedures into clinical practice.
authors.affiliation: Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. verena.metz@meduniwien.ac.at
authors.forename: Verena
authors.initials: V
authors.lastname: Metz
authors.forename: Reinhold
authors.initials: R
authors.lastname: Jagsch
authors.forename: Nina
authors.initials: N
authors.lastname: Ebner
authors.forename: Johanna
authors.initials: J
authors.lastname: Würzl
authors.forename: Anna
authors.initials: A
authors.lastname: Pribasnig
authors.forename: Constantin
authors.initials: C
authors.lastname: Aschauer
authors.forename: Gabriele
authors.initials: G
authors.lastname: Fischer
mesh_terms: D000328:Adult; D001317:Austria; D001724:Birth Weight; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007902:Length of Stay; D008297:Male; D008691:Methadone / Q000008:administration & dosage* / Q000009:adverse effects; D009020:Morphine / Q000008:administration & dosage; D009357:Neonatal Abstinence Syndrome / Q000188:drug therapy / Q000453:epidemiology; D058850:Opiate Substitution Treatment / Q000379:methods; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D011446:Prospective Studies; D013997:Time Factors; D055815:Young Adult
chemical_list: D002047:Buprenorphine; D009020:Morphine; D008691:Methadone