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NEXUS Ultrasound Intervention for Substance Use Disorders in Pregnancy (NEXUS Trial)

N/A
Recruiting
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following infant birth
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a community-based intervention to reduce health disparities faced by mothers and their children impacted by substance use disorder.

Who is the study for?
This trial is for pregnant individuals aged 18-45, between 22-32 weeks gestation, who have a substance use disorder or are in treatment for it. They must understand English and be willing to follow the study procedures including the NEXUS regimen. Excluded are those with known fetal anomalies, cognitive impairments, psychiatric instability, language/legal barriers, or conditions needing frequent ultrasounds like Gestational Diabetes.
What is being tested?
The NEXUS intervention combines motivational interviewing techniques with strength-based education and healthcare coordination strategies using a specialized fetal ultrasound protocol. It aims to improve maternal-fetal health among women affected by substance use disorders compared to standard non-medical fetal ultrasound care.
What are the potential side effects?
Since this trial involves non-invasive interventions such as educational sessions and ultrasounds rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort discussing sensitive topics during interviews.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following infant birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following infant birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parent Subjective Connection to Fetus/Infant
Prenatal care utilization
Study Retention
+1 more
Secondary study objectives
Access to Care
Obstetric complications
Perceived Stress
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NEXUS InterventionExperimental Treatment2 Interventions
Standardized non-diagnostic fetal ultrasound with motivational interviewing techniques, focused on maternal and fetal strengths.
Group II: ComparatorActive Control1 Intervention
Standardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
714 Previous Clinical Trials
22,888,335 Total Patients Enrolled

Media Library

NEXUS intervention Clinical Trial Eligibility Overview. Trial Name: NCT05814575 — N/A
Pregnancy Research Study Groups: Comparator, NEXUS Intervention
Pregnancy Clinical Trial 2023: NEXUS intervention Highlights & Side Effects. Trial Name: NCT05814575 — N/A
NEXUS intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814575 — N/A
~19 spots leftby Aug 2025
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