Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
- Conditions
- Opioid Use, UnspecifiedOpioid-use DisorderBuprenorphine Dependence
- Interventions
- Diagnostic Test: Fetal & Neonatal MRIDiagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
- Registration Number
- NCT03923374
- Lead Sponsor
- Senthil Sadhasivam
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 600
- 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
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant Mothers with Opioid Use Disorder DNA/Genetic/Pharmacokenetic Blood Draws Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine Pregnant Mothers DNA/Genetic/Pharmacokenetic Blood Draws Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder. Pregnant Mothers with Opioid Use Disorder Subutex / Buprenorphine Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine Pregnant Mothers with Opioid Use Disorder Fetal & Neonatal MRI Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine Pregnant Mothers Fetal & Neonatal MRI Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder.
- Primary Outcome Measures
Name Time Method Incidence of opioid misuse severity using assessments 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 5 years Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
- Secondary Outcome Measures
Name Time Method Incidence of adverse effects of buprenorphine using MRI 5 years Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
Concentration of long-term neurodevelopmental outcomes using assessments 5 years Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
Trial Locations
- Locations (1)
UPMC Children's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States