Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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.
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.
Location
- UPMC Children's HospitalPittsburgh, Pennsylvania