Trials / Recruiting
RecruitingNCT03923374
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Senthil Sadhasivam · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).
Detailed description
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Subutex / Buprenorphine | Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder. |
| DIAGNOSTIC_TEST | Fetal & Neonatal MRI | Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI. |
| DIAGNOSTIC_TEST | DNA/Genetic/Pharmacokenetic Blood Draws | Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples. |
Timeline
- Start date
- 2018-09-15
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
- First posted
- 2019-04-22
- Last updated
- 2025-12-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03923374. Inclusion in this directory is not an endorsement.