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

NCT03923374 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-12-18

No results posted yet for this study

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).

Conditions

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

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Senthil Sadhasivam

    lead OTHER

Principal Investigators

  • Senthil Sadhasivam, MD, MPH · University of Pittsburgh, UPMC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923374 on ClinicalTrials.gov