The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.
Study Type
OBSERVATIONAL
Enrollment
92
buprenorphine or methadone concentration measurement
Caen University Hospital
Caen, France
meconium concentration of buprenorphine
Time frame: variation over time at baseline and 24hrs to 48hrs after birth
meconium concentration of methadone
Time frame: variation over time at baseline and 24hrs to 48hrs after birth
urine concentration of buprenorphine or methadone
Time frame: baseline and 24hrs to 48hrs after birth
by the score of Lipsitz,
Clinical evaluation of the newborn
Time frame: 4 times a day when the newborn is awake from baseline to 48hrs
screening of other drugs in mother's urine and meconium
Time frame: baseline and 24hrs to 48hrs after birth
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