RecruitingNCT03923374

Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes


Sponsor

Senthil Sadhasivam

Enrollment

600 participants

Start Date

Sep 15, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying DNA/Genetic/Pharmacokenetic Blood Draws, Fetal & Neonatal MRI, and others for people with buprenorphine dependence, opioid use, unspecified, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSubutex / Buprenorphine

Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

DIAGNOSTIC_TESTFetal & Neonatal MRI

Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

DIAGNOSTIC_TESTDNA/Genetic/Pharmacokenetic Blood Draws

Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.


Locations(1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, United States

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NCT03923374


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