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

C

Caen University Hospital

Status

Completed

Conditions

Neonatal Abstinence Syndrome

Treatments

Procedure: Concentrations in Meconium of Buprenorphine and Methadone

Study type

Observational

Funder types

Other

Identifiers

NCT03334981
11-061

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

92 participants in 1 patient group

exposed mother and child
Description:
mother and child who have been exposed to methadone or to buprenorphine during pregnancy
Treatment:
Procedure: Concentrations in Meconium of Buprenorphine and Methadone

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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