Neonatal Abstinence Syndrome
Conditions
Keywords
meconium concentration, buprenorphine, methadone, pregnant, liquid chromatography-tandem mass spectrometry, opioid-dependant woman
Brief summary
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.
Interventions
PROCEDUREConcentrations in Meconium of Buprenorphine and Methadone
buprenorphine or methadone concentration measurement
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged over 18 years * pregnant women * Having agreed to participate in the study after information * Under opioid replacement therapy during pregnancy, in combination or not with other psychotropic drugs or legal or illegal substances. * Delivery after more than 34 weeks of amenorrhea
Exclusion criteria
* Pregnant women not receiving substitution treatment (methadone or buprenorphine). * Patient under substitution treatment delivering before 34 weeks of amenorrhea * Patient aged under 18 yrs old * Patient unable to understand the study (mental deficiency, impairment of consciousness, not French) or not accepting to answer the questionnaires. * Severe malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy. * mother's death or newborn's death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| meconium concentration of buprenorphine | variation over time at baseline and 24hrs to 48hrs after birth |
| meconium concentration of methadone | variation over time at baseline and 24hrs to 48hrs after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urine concentration of buprenorphine or methadone | baseline and 24hrs to 48hrs after birth | — |
| by the score of Lipsitz, | 4 times a day when the newborn is awake from baseline to 48hrs | Clinical evaluation of the newborn |
| screening of other drugs in mother's urine and meconium | baseline and 24hrs to 48hrs after birth | — |
Countries
France
Outcome results
None listed