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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- meconium concentration of buprenorphine
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
meconium concentration of buprenorphine
时间窗: variation over time at baseline and 24hrs to 48hrs after birth
meconium concentration of methadone
时间窗: variation over time at baseline and 24hrs to 48hrs after birth
次要结局
- 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)
- screening of other drugs in mother's urine and meconium(baseline and 24hrs to 48hrs after birth)