Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Senthil Sadhasivam
600 participants
Sep 15, 2018
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
Inclusion Criteria4
- 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 Criteria2
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
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Interventions
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
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)
View Full Details on ClinicalTrials.gov
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NCT03923374