NEXUS - Next Generation Health Through 2D & 3D Fetal UltraSound; Building Connections to Support Maternal-fetal Health

NCT05814575 | Completed DMC

• 1 other identifier: HM20025280
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study brings together an interprofessional team, novel tools, and innovative, community-driven care delivery approaches to improve health equity among mother-infant dyads impacted by substance use disorder and high risk for poor health outcomes. This study will test a community-informed and community-based intervention using a fetal ultrasound protocol, motivational interviewing techniques, strength-based education, and healthcare coordination strategies to reduce health disparities faced by women and their children.

Conditions

Pregnancy Related; Substance Use; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• Study Retention

  Percentage of each group returning for a second study visit

  10-26 weeks

• Parent Subjective Connection to Fetus/Infant

  Participants reported scores of maternal-fetal attachment at the Baseline visit and at last postpartum session; Maternal-fetal attachment scale; Parent-Infant Attachment Questionnaire at 12 weeks post-delivery; (0-5 score, higher is better)

  Baseline through 12 Weeks post-delivery

• Prenatal care utilization

  The number of prenatal care visits per week of gestation at delivery.

  Immediately following infant birth

• Substance use treatment utilization

  The number of substance use and mental health treatment visits per week of gestation at delivery.

  Immediately following infant birth

Secondary Outcomes (4)

• Access to Care

  26 weeks

• Perceived Stress

  26 weeks

• Substance use in pregnancy

  Immediately following infant birth

• Obstetric complications

  12 weeks postpartum

Study Arms (2)

Comparator

ACTIVE COMPARATOR

Standardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention.

Behavioral: Standardized Non-Medical fetal ultrasound

NEXUS Intervention

EXPERIMENTAL

Standardized non-diagnostic fetal ultrasound with motivational interviewing techniques, focused on maternal and fetal strengths.

Behavioral: NEXUS intervention; Behavioral: Standardized Non-Medical fetal ultrasound

Interventions

NEXUS intervention BEHAVIORAL

During the fetal ultrasound protocol, the NEXUS intervention is added for the component of 'attachment promotion' as it is a natural extension to share with the pregnant person the behavioral and social strengths of their unborn child. As the participant observes the fetus on the monitor (a second external monitor is set up for easy viewing by the mother), she may also feel fetal movement simultaneously in the womb (after 23 weeks gestation), creating a visual and sensory link between the mother and fetus. A trained nurse or ultrasonographer shares observations of fetal behavior with the mother and others if present. The nurse is also trained in motivational interviewing techniques to use the strengths of the mother and those attributed to her fetus to explore readiness to change and other motivational factors that may be barriers to health promotion.

NEXUS Intervention

Standardized Non-Medical fetal ultrasound BEHAVIORAL

A standardized protocol using non-diagnostic fetal ultrasound that includes basic maternal-fetal health assessment by a trained nurse, fetal neurobehavioral assessment, measures of fetal growth, and pictures \& videos given to parents.

Comparator; NEXUS Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean for Research

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 18, 2023
• Study Start: June 8, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

US (1)