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

Neonatal Abstinence Syndrome Clinical Trial

— SUBOPGEST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334981
• Other study ID #: 11-061
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: November 3, 2017
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Procedure:
• Concentrations in Meconium of Buprenorphine and Methadone
buprenorphine or methadone concentration measurement

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meconium concentration of buprenorphine		variation over time at baseline and 24hrs to 48hrs after birth
Primary	meconium concentration of methadone		variation over time at baseline and 24hrs to 48hrs after birth
Secondary	urine concentration of buprenorphine or methadone		baseline and 24hrs to 48hrs after birth
Secondary	by the score of Lipsitz,	Clinical evaluation of the newborn	4 times a day when the newborn is awake from baseline to 48hrs
Secondary	screening of other drugs in mother's urine and meconium		baseline and 24hrs to 48hrs after birth