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

NCT ID: NCT03334981

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Abstinence Syndrome

Keywords

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meconium concentration buprenorphine methadone pregnant liquid chromatography-tandem mass spectrometry opioid-dependant woman

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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exposed mother and child

mother and child who have been exposed to methadone or to buprenorphine during pregnancy

Concentrations in Meconium of Buprenorphine and Methadone

Intervention Type PROCEDURE

buprenorphine or methadone concentration measurement

Interventions

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Concentrations in Meconium of Buprenorphine and Methadone

buprenorphine or methadone concentration measurement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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11-061

Identifier Type: -

Identifier Source: org_study_id