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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Conditions
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Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence

Intervention / Treatment
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* Drug: Subutex / Buprenorphine
* Diagnostic Test: Fetal & Neonatal MRI
* Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Mothers with Opioid Use Disorder<br>Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine | Drug: Subutex / Buprenorphine<br>* Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.<br>Diagnostic Test: Fetal & Neonatal MRI<br>* Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.<br>Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws<br>* 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.<br>|
| Pregnant Mothers<br>Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder. | Diagnostic Test: Fetal & Neonatal MRI<br>* Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.<br>Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of opioid misuse severity using assessments | Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D. | 5 years | 
| Pharmacological treatment for neonatal abstinence syndrome | Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effects of buprenorphine using MRI | Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI. | 5 years | 
| Concentration of long-term neurodevelopmental outcomes using assessments | Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant with Opioid Use Disorder, Opioid Use Disorder ( OUD), Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex