Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
NCT ID: NCT03923374
Last Updated: 2025-12-18
Study Results
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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RECRUITING
600 participants
OBSERVATIONAL
2018-09-15
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine
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.
Subutex / Buprenorphine
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Pregnant Mothers
Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of 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.
Interventions
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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.
Subutex / Buprenorphine
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Eligibility Criteria
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Inclusion Criteria
* Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.
* Pregnant with single baby
* Planned delivery at Methodist, University or Riley Hospital
Exclusion Criteria
* Known or suspected major fetal/neonatal congenital abnormalities.
18 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Senthil Sadhasivam
OTHER
Responsible Party
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Senthil Sadhasivam
Professor
Principal Investigators
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Senthil Sadhasivam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh, UPMC
Locations
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UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Senthil M Sadhasivam, MD, MPH
Role: primary
Carly Riedmann, MPH
Role: backup
Other Identifiers
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STUDY21110112
Identifier Type: -
Identifier Source: org_study_id