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Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Senthil Sadhasivam

Start Date

9/15/2018

Completion Date

12/30/2026

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

DRUG

Subutex / Buprenorphine

DIAGNOSTIC_TEST

Fetal & Neonatal MRI

DIAGNOSTIC_TEST

DNA/Genetic/Pharmacokenetic Blood Draws

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Conditions

Opioid-use DisorderOpioid Use, UnspecifiedBuprenorphine Dependence

Locations

UPMC Children's Hospital

Pittsburgh, Pennsylvania 15224

United States