Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Caen

Conditions:

Neonatal Abstinence Syndrome

Eligibility:

FEMALE

18+ years

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2015

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT03334981

Start Date

July 1 2012

End Date

July 1 2015

Last Update

November 7 2017

Active Locations (1)

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Caen University Hospital

Caen, France