Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws.
- Who it may be relevant to
- Registry conditions: Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Overview
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).
Detailed description
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
Interventions
- Drug Subutex / Buprenorphine
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder. - Diagnostic test Fetal & Neonatal MRI
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI. - Diagnostic test 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.
Primary outcome measures
- Incidence of opioid misuse severity using assessments [Time frame: 5 years]
- Pharmacological treatment for neonatal abstinence syndrome [Time frame: 5 years]
Secondary outcome measures (2)
- Incidence of adverse effects of buprenorphine using MRI [Time frame: 5 years]
- Concentration of long-term neurodevelopmental outcomes using assessments [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age greater 18 years
- 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
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- UPMC Children's Hospital — Pittsburgh
Identifiers
NCT: NCT03923374 · STUDY21110112 · 1R01HD096800-01