Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06415994
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 child's development milestones and at one year of life they will undergo a development assessment.
Study:
NCT06415994
Study Brief:
Protocol Section:
NCT06415994