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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Pittsburgh, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported