Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
R
Rupa Radhakrishnan, MD
Primary Investigator
Recruiting
18 years - 100 years
Female
Phase
N/A
150 participants needed
2 Locations
Brief description of study
Why is this study being done?
This research study is being done to improve outcomes in mothers who have taken opioids during pregnancy and their newborn babies. We want to learn more about how the placenta functions and how the fetal brain develops when exposed to opioids. We also want to learn if there are any long-term effects on newborn babies, compared to babies whose mothers did not take opioids during pregnancy. We want to follow mothers and babies over approximately one year to look at genetic, social, environmental, and psychological reasons that affect mothers who take opioids and their babies.
Who can take part?
Women who are 16-32 weeks pregnant and/or have been referred by the pregnancy . We are interested in following participants from pregnancy through the child’s 1st year of life. .
Additional information
Study title: Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
The study is being conducted by Dr. Rupa Radhakrishnan, MS, MD, with the Indiana University School of Medicine, Department of Radiology at Riley Hospital for Children. This study is being funded by the National Institutes of Health (NIH), specifically the National Institute of Drug Abuse (NIDA) and the Helping to End Addiction Long Term (HEAL) initiative.
To learn more about Rupa Radhakrishnan and her research interests, please visit this link: https://medicine.iu.edu/faculty/38670/radhakrishnan-rupa
Detailed description of study
What happens during study participation?
- Complete questionnaires on your social and medical history
- Attend 2 MRI visits during 2nd and 3rd trimester to evaluate your placenta and your baby’s brain development (fetal MRIs will take about 45min-1 hour; we expect the total length to take about 2 hours for each visit).
- Blood samples and placenta collection (if possible)
- Developmental surveys for child during the first year of life.
- Developmental assessment at one year of age .
Incentive/compensation
- Participants will receive up to $670 that is on a VISA card throughout the study.
- Transportation can be provided upon request
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Opioid Use Disorder, OUD, Pregnancy, Prenatal Opioid Exposure
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Age: 18 years - 100 years
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Gender: Female
Pregnant women with opioid use disorder
Inclusion criteria
- Age > 18yrs
- Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
- Singleton Pregnancy
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 criteria:
- Prenatal buprenorphine or methadone exposure
- Born to mother enrolled in Opioid Use Disorder arm of study
Exclusion criteron:
- Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control pregnant women:
Inclusion Criteria:
- Woman >18yrs of age
healthy singleton pregnancy
Exclusion Criteria:
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- HIV or AIDS
- Known or suspected major fetal congenital abnormalities
- Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
- Substance use noted on urine screening
Control infants:
Inclusion criteron:
- Born to control pregnant mother enrolled in study
Exclusion criterion:
- Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Updated on
07 Jan 2025.
Study ID: RADY-IIR-19751, 19751
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