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RECRUITING
NCT03923374

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

Sponsor: Senthil Sadhasivam

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2018-09-15

Completion Date

2026-12-30

Last Updated

2025-12-18

Healthy Volunteers

Yes

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.

Locations (1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, United States