Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (Mother/BabyOUD)

Senthil Sadhasivam

Status: Enrolling

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

Treatments: Drug: Subutex / Buprenorphine; Diagnostic Test: Fetal & Neonatal MRI; Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03923374

STUDY21110112

1R01HD096800-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

Pregnant Mothers with Opioid Use Disorder

Description:

Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine

Treatment:

Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws

Diagnostic Test: Fetal & Neonatal MRI

Drug: Subutex / Buprenorphine

Pregnant Mothers

Description:

Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder.

Treatment:

Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws

Diagnostic Test: Fetal & Neonatal MRI