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Completed

NCT Number: NCT03334981

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

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.

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concentrations in Meconium of Buprenorphine and Methadone

Procedure

buprenorphine or methadone concentration measurement

Primary outcomes

  1. meconium concentration of buprenorphine

    Time frame: variation over time at baseline and 24hrs to 48hrs after birth

  2. meconium concentration of methadone

    Time frame: variation over time at baseline and 24hrs to 48hrs after birth

Secondary outcomes

  1. urine concentration of buprenorphine or methadone

    Time frame: baseline and 24hrs to 48hrs after birth

  2. by the score of Lipsitz,

    Time frame: 4 times a day when the newborn is awake from baseline to 48hrs

    Clinical evaluation of the newborn

  3. screening of other drugs in mother's urine and meconium

    Time frame: baseline and 24hrs to 48hrs after birth

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: SUBOPGEST

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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