Improving maternal-fetal health through innovative ultrasound and community support
Community-based Fetal Ultrasound and Care Navigation: An Approach to Engaging Pregnant Women With Substance Use Disorder in Prenatal Care and Substance Use Treatment
This study is testing a new approach that combines special ultrasound techniques and community support to help pregnant people with substance use disorders get better care for themselves and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05814575 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to enhance health equity for mother-infant pairs affected by substance use disorders by implementing a community-informed intervention. It utilizes a novel fetal ultrasound protocol alongside motivational interviewing and care coordination strategies to engage pregnant individuals in early and consistent prenatal care. The intervention focuses on fostering a connection between the mother and fetus, which is expected to motivate healthier behaviors and improve health outcomes. By addressing the unique challenges faced by this population, the study seeks to reduce health disparities and promote better maternal and infant health.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 to 45, between 22-32 weeks gestation, who have a history of substance use disorder or are currently in treatment.
Not a fit: Patients with cognitive impairments, psychiatric instability, or known fetal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved prenatal care and health outcomes for mothers and their infants affected by substance use disorders.
How similar studies have performed: While this approach is innovative, similar community-based interventions have shown promise in improving health outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant persons, Aged 18 through 45, between 22-32 weeks gestation at study entry * Provision of signed and dated informed consent form * Not incarcerated * Able to read and understand English * For infants after delivery, parental informed consent to participate in the study * Stated willingness to comply with all study procedures * Meets Diagnostic and Statistical Manual 5 criteria for Substance Abuse or substance use disorder in the last 12 months or is in active treatment for substance use disorder (including Nicotine/Tobacco, alcohol, marijuana, illicit and licit substances, and opioids) or actively using substances during pregnancy. * Willingness to participate in the NEXUS regimen Exclusion Criteria: * Presenting with cognitive impairment * psychiatric instability (active psychosis or acute mania) * language or legal barriers that would limit the patient's ability to provide informed consent and complete research assessments. * Known fetal anomalies * Medical conditions requiring frequent ultrasound monitoring outside the study (e.g. Gestational Diabetes)
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Andrea Publow
- Email: dirospa@vcu.edu
- Phone: 804-828-6772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.