Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415994
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2024-03-04
Brief Title:
Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure The main objectives are
Long term goal to improve the safety and efficacy of maternal Opioid Use Disorder OUD and eliminate neonatal opioid withdrawal syndrome NOWS and poor childhood neurodevelopment
To characterize prenatal opioid exposure POE related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging MRI and determine proteomic genomic and epigenetic signatures of NOWS and poor infant neurodevelopment
In this study participants will
Receive two placental-fetal MRIs one during second trimester and one in third trimester
Answer surveys relating to their medical and social history
Have blood drawn during pregnancy and delivery
Child development follow up answer surveys on their childs development milestones and at one year of life they will undergo a development assessment
Long term goal to improve the safety and efficacy of maternal Opioid Use Disorder OUD and eliminate neonatal opioid withdrawal syndrome NOWS and poor childhood neurodevelopment
To characterize prenatal opioid exposure POE related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging MRI and determine proteomic genomic and epigenetic signatures of NOWS and poor infant neurodevelopment
In this study participants will
Receive two placental-fetal MRIs one during second trimester and one in third trimester
Answer surveys relating to their medical and social history
Have blood drawn during pregnancy and delivery
Child development follow up answer surveys on their childs development milestones and at one year of life they will undergo a development assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA059321 | NIH | None | httpsreporternihgovquickSearchR01DA059321 |