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Search / Trial NCT06415994

Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

Launched by INDIANA UNIVERSITY · May 14, 2024

Trial Information

Current as of July 01, 2025

Enrolling by invitation

Keywords

Pregnant With Opioid Use Disorder Opioid Use Disorder Subutex Buprenorphine Pregnant Taking Buprenorphine/Subutex

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Pregnant women with opioid use disorder
  • Inclusion Criteria:
  • Age \>18 years
  • Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
  • Singleton Pregnancy
  • Planned delivery at Indiana University or University of Pittsburgh study sites
  • Exclusion Criteria:
  • Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
  • Known or suspected major fetal/ neonatal congenital abnormalities
  • HIV or AIDS
  • Infants with prenatal opioid exposure:
  • Inclusion:
  • 1. Prenatal buprenorphine or methadone exposure
  • 2. Born to mother enrolled in Opioid Use Disorder arm of study
  • Exclusion:
  • Major congenital anomalies or genetic syndromes affecting neurodevelopment
  • Control Pregnant Women:
  • Inclusion:
  • 1. Women \>18 Years of age
  • 2. Healthy singleton pregnancy
  • 3. Planned delivery at Indiana University or University of Pittsburgh study sites
  • Exclusion:
  • 1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
  • 2. HIV or AIDS
  • 3. Known or suspected major fetal congenital abnormalities
  • 4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
  • Control infants:
  • Inclusion:
  • Born to control pregnant mother enrolled in study
  • Exclusion:
  • Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Pittsburgh, Pennsylvania, United States

Pittsburg, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported