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).

Full Title of Study: “Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2023

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.

Arms, Groups and Cohorts

  • Pregnant Mothers with Opioid Use Disorder
    • Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine
  • Pregnant Mothers
    • Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of opioid misuse severity using assessments
    • Time Frame: 5 years
    • 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.
  • Pharmacological treatment for neonatal abstinence syndrome
    • Time Frame: 5 years
    • Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Senthilkumar Sadhasivam, MD, MPH, Principal Investigator – Indiana University

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