Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Neonatal Abstinence Syndrome

Intervention / Treatment
-----------------
* Procedure: Concentrations in Meconium of Buprenorphine and Methadone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exposed mother and child<br>mother and child who have been exposed to methadone or to buprenorphine during pregnancy | Procedure: Concentrations in Meconium of Buprenorphine and Methadone<br>* buprenorphine or methadone concentration measurement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine concentration of buprenorphine or methadone |  | baseline and 24hrs to 48hrs after birth | 
| by the score of Lipsitz, | Clinical evaluation of the newborn | 4 times a day when the newborn is awake from baseline to 48hrs | 
| screening of other drugs in mother's urine and meconium |  | baseline and 24hrs to 48hrs after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methadone, meconium concentration, buprenorphine, pregnant, liquid chromatography-tandem mass spectrometry, opioid-dependant woman