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Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Sponsor: Senthil Sadhasivam
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).
Official title: Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2018-09-15
Completion Date
2026-12-30
Last Updated
2025-12-18
Healthy Volunteers
Yes
Interventions
Subutex / Buprenorphine
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Fetal & Neonatal MRI
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
DNA/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