Pregnancy RelatedNEXUSNCT05814575
NEXUS - Next Generation Health Through 2D & 3D Fetal UltraSound; Building Connections to Support Maternal-fetal Health
A study testing NEXUS intervention and Standardized Non-Medical fetal ultrasound in people with Pregnancy Related and Substance Use, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Substance Use, Mental Health Issue
- What is being tested?
- NEXUS intervention and Standardized Non-Medical fetal ultrasound
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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 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.
Read the detailed description
Engaging women earlier in pregnancy through innovative, yet sustainable methods, will improve consistency in prenatal care and substance use treatment which will translate into substantially improved maternal and infant outcomes. The overarching premise is that successful engagement of women in accessible care during pregnancy will lead to earlier and more sustained prenatal care and treatment and lower risk for poor outcomes. This study is a multi-pronged approach to offer: (1) community-informed and community-located protocols to engage individuals into prenatal care as early as possible; (2) a novel fetal ultrasound protocol to enhance maternal-fetal connection and stimulate motivation for self-management and prenatal care; and, (3) navigation and care coordination, to connect individuals to personalized services and treatment. The NEXUS intervention is based on the idea that visualizing the fetus and seeing behavioral patterns in-utero will increase a person's sense of attachment to the fetus and in turn increase motivation for self-care and avoidance of risky behaviors. The NEXUS protocol includes a standardized fetal neurobehavioral assessment, measures of fetal growth, and, importantly, a 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 woman 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 family is given pictures and videos of the infant to take home with them. The NEXUS protocol will be repeated approximately 4 weeks after the first session, with educational content focused on the development of the fetus, changes in physical function, behaviors, and growth.
This is a small community-based randomized control trial in which 60 pregnant women with substance use disorder (or treatment for substance use disorder) will be offered two prenatal study visits, between the 2nd and 3rd trimesters, with two follow-up visits in the first 4 months after infant delivery. Participants will be recruited from communities with high health disparities and randomly assigned to either: (1) the Comparator Group which receives a standard non-diagnostic ultrasound with minimal interaction and no accompanying education or, (2) NEXUS Intervention Group which receives the NEXUS fetal ultrasound protocol that includes motivational interviewing and content specific to emotional and cognitive connection with the fetus. The prenatal ultrasound visits and the follow-up visits will be offered within the community in which the participant lives. All participants will receive standardized education, care coordination, and weekly contact with care navigators.
- Conditions
- Pregnancy Related, Substance Use, Mental Health Issue
- Being tested
- NEXUS intervention, Standardized Non-Medical fetal ultrasound
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEXUS interventionBehavioural
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.
Standardized Non-Medical fetal ultrasoundBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Standardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention. Receives: Behavioral: Standardized Non-Medical fetal ultrasound |
| NEXUS Intervention | Experimental | Standardized non-diagnostic fetal ultrasound with motivational interviewing techniques, focused on maternal and fetal strengths. Receives: Behavioral: NEXUS intervention; Behavioral: Standardized Non-Medical fetal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Retention
Percentage of each group returning for a second study visit
Measured: 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)
Measured: Baseline through 12 Weeks post-delivery
Prenatal care utilization
The number of prenatal care visits per week of gestation at delivery.
Measured: Immediately following infant birth
Substance use treatment utilization
The number of substance use and mental health treatment visits per week of gestation at delivery.
Measured: Immediately following infant birth
Secondary outcomes (4)
Access to Care
PRAMS access to care survey
Measured: 26 weeks
Perceived Stress
Perceived Stress Scale
Measured: 26 weeks
Substance use in pregnancy
Participants' reported substance use at weekly check-ins during and after pregnancy: total number of days using substances in pregnancy (tobacco, alcohol, illicit drugs, marijuana).
Measured: Immediately following infant birth
Obstetric complications
The total number of Obstetrics Complications identified by participant reports and medical record occurring from pregnancy through 12 weeks postpartum.
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start8 Jun 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Amy Salisbury, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814575
- Sponsor's protocol ID
- HM20025280
- Other IDs
- 1R21DA058407
- Acronym
- NEXUS
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data will be shared in a standard data repository.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Fetal Ultrasound and Care Navigation: An Approach to Engaging Pregnant Women With Substance Use Disorder in Prenatal Care and Substance Use Treatment
- ClinicalTrials.gov ID
- NCT05814575
- Acronym / sponsor ID
- NEXUS / HM20025280
- Conditions
- Pregnancy Related, Substance Use, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Engaging women earlier in pregnancy through innovative, yet sustainable methods, will improve consistency in prenatal care and substance use treatment which will translate into substantially improved maternal and infant outcomes. The overarching premise is that successful engagement of women in accessible care during pregnancy will lead to earlier and more sustained prenatal care and treatment and lower risk for poor outcomes. This study is a multi-pronged approach to offer: (1) community-informed and community-located protocols to engage individuals into prenatal care as early as possible; (2) a novel fetal ultrasound protocol to enhance maternal-fetal connection and stimulate motivation for self-management and prenatal care; and, (3) navigation and care coordination, to connect individuals to personalized services and treatment. The NEXUS intervention is based on the idea that visualizing the fetus and seeing behavioral patterns in-utero will increase a person's sense of attachment to the fetus and in turn increase motivation for self-care and avoidance of risky behaviors. The NEXUS protocol includes a standardized fetal neurobehavioral assessment, measures of fetal growth, and, importantly, a 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 woman 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 family is given pictures and videos of the infant to take home with them. The NEXUS protocol will be repeated approximately 4 weeks after the first session, with educational content focused on the development of the fetus, changes in physical function, behaviors, and growth.
This is a small community-based randomized control trial in which 60 pregnant women with substance use disorder (or treatment for substance use disorder) will be offered two prenatal study visits, between the 2nd and 3rd trimesters, with two follow-up visits in the first 4 months after infant delivery. Participants will be recruited from communities with high health disparities and randomly assigned to either: (1) the Comparator Group which receives a standard non-diagnostic ultrasound with minimal interaction and no accompanying education or, (2) NEXUS Intervention Group which receives the NEXUS fetal ultrasound protocol that includes motivational interviewing and content specific to emotional and cognitive connection with the fetus. The prenatal ultrasound visits and the follow-up visits will be offered within the community in which the participant lives. All participants will receive standardized education, care coordination, and weekly contact with care navigators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Behavioral: Standardized Non-Medical fetal ultrasoundStandardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention. |
| NEXUS Intervention | Experimental | Behavioral: NEXUS intervention, Behavioral: Standardized Non-Medical fetal ultrasoundStandardized non-diagnostic fetal ultrasound with motivational interviewing techniques, focused on maternal and fetal strengths. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEXUS interventionDuring 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. | Behavioural | NEXUS Intervention |
| Standardized Non-Medical fetal ultrasoundA 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. | Behavioural | Comparator, NEXUS Intervention |
Primary outcome
Study Retention
Time frame: 10-26 weeks
Percentage of each group returning for a second study visit
Parent Subjective Connection to Fetus/Infant
Time frame: Baseline through 12 Weeks post-delivery
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)
Prenatal care utilization
Time frame: Immediately following infant birth
The number of prenatal care visits per week of gestation at delivery.
Substance use treatment utilization
Time frame: Immediately following infant birth
The number of substance use and mental health treatment visits per week of gestation at delivery.
4 secondary outcomes
Access to Care
Time frame: 26 weeks
Perceived Stress
Time frame: 26 weeks
Substance use in pregnancy
Time frame: Immediately following infant birth
Obstetric complications
Time frame: 12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized participant data will be shared in a standard data repository.
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEXUS intervention and Standardized Non-Medical fetal ultrasound in people with Pregnancy Related and Substance Use, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Retention (time frame: 10-26 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.