NEXUS Ultrasound Intervention for Substance Use Disorders in Pregnancy

(NEXUS Trial)

Overseen By Andrea Publow

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cognitive impairment, Psychiatric instability, Fetal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to support pregnant women with substance use disorders by testing a new approach called the NEXUS intervention. This study combines fetal ultrasound with motivational talks and education to assist mothers and their babies. Participants will either receive this new intervention or a standard ultrasound without the additional components. Pregnant women who have used substances in the past year or are currently using them, and are between 22-32 weeks pregnant, may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance care for mothers and babies in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this ultrasound protocol is safe for pregnant women with substance use disorders?

Research shows that the NEXUS approach, which combines a special type of ultrasound with motivational conversations, is safe. Ultrasounds have been safely used during pregnancy for many years to check the baby's health, and no evidence suggests that the ultrasound used in this study harms the mother or baby.

Motivational interviewing, part of the NEXUS approach, is a technique that helps people make positive life changes. It involves conversations that encourage and motivate individuals to find personal reasons to change, with no known safety concerns.

In summary, the NEXUS approach uses well-known and safe practices. Research has not reported any negative effects from these techniques, indicating they are safe for both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NEXUS Ultrasound Intervention because it combines traditional fetal ultrasound with motivational interviewing techniques, a new approach in managing substance use disorders during pregnancy. Unlike standard care options that primarily focus on counseling and medication, this method emphasizes maternal and fetal strengths to encourage healthier choices. The integration of motivational interviewing with ultrasound is designed to engage expectant mothers on a deeper level, potentially leading to improved outcomes for both the mother and baby.

What evidence suggests that this trial's interventions could be effective for substance use disorders in pregnancy?

Research has shown that the NEXUS program, which participants in this trial may receive, includes baby ultrasounds and motivational conversations that may assist pregnant women struggling with substance use. Viewing the baby through ultrasounds can strengthen the mother-baby bond, leading to improved care during pregnancy. These ultrasounds may also reduce anxiety and depression, common during pregnancy. Motivational conversations, a method that helps individuals find personal reasons to change, have proven effective in supporting positive behavior changes. Together, these methods aim to enhance the health of both mother and baby by promoting healthy actions and reducing health risks. Another group in this trial will receive a standardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures

Not incarcerated

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive the NEXUS fetal ultrasound protocol with motivational interviewing and education focused on maternal-fetal connection

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for substance use treatment utilization and maternal-fetal attachment after delivery

12 weeks postpartum

2 visits (in-person)

Postpartum Monitoring

Participants' perceived stress and obstetric complications are assessed

12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• NEXUS intervention
• Standardized Non-Medical fetal ultrasound

Trial Overview 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.

How Is the Trial Designed?

Group I: NEXUS Intervention Experimental Treatment 2 Interventions

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

Group II: Comparator Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

The Perinatal Wellness Navigator (PWN) program, tested on 50 high-risk perinatal women (42 with opioid use disorder), led to a significant reduction in daily cigarette consumption by an average of 10 cigarettes and decreased nicotine dependence after the intervention.

Participants also reported lower levels of postnatal depression and perceived stress, indicating that while total tobacco abstinence was not achieved, the program effectively improved overall mental health and reduced smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Navigator Approach to Smoking Cessation for Women With Prevalent Opioid Dependence. Fallin-Bennett, A., Rademacher, K., Dye, H., et al.[2020]

Substance use during pregnancy is common and often overlooked, but implementing universal screening can help identify women at different risk levels for substance use, allowing for tailored interventions.

The recommended approach includes brief advice for low-risk women, brief interventions for moderate-risk women, and referrals to specialty care for high-risk women, which can significantly reduce the negative impacts of substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of screening, brief intervention, and referral to treatment in the perinatal period. Wright, TE., Terplan, M., Ondersma, SJ., et al.[2022]

The e-SBI-HV is a newly developed digital screening and brief intervention program tailored for home visiting contexts, designed to help pregnant and postpartum women address substance use while maintaining confidentiality and avoiding fears of child protective services involvement.

Based on user-centered design involving 24 participants (17 home visitors and 7 clients), the e-SBI-HV addresses specific needs and concerns of the target population, showing promise in filling gaps in home visiting services for substance use support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Electronic Screening and Brief Intervention to Address Perinatal Substance Use in Home Visiting: Qualitative User-Centered Approach. Dauber, S., Hammond, C., Hogue, A., et al.[2023]

A new prenatal intervention for substance-abusing pregnant women was developed in a public healthcare setting in Finland, focusing on enhancing maternal curiosity about their developing child and motivating abstinence from substance use.

The intervention includes interactive ultrasound consultations and a pregnancy diary, both designed to promote parental mentalization, and was evaluated with a sample of 90 participants, highlighting its potential applicability to other groups and settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUBSTANCE-ABUSING PREGNANT WOMEN: PRENATAL INTERVENTION USING ULTRASOUND CONSULTATION AND MENTALIZATION TO ENHANCE THE MOTHER-CHILD RELATIONSHIP AND REDUCE SUBSTANCE USE. Pajulo, H., Pajulo, M., Jussila, H., et al.[2017]

Buprenorphine was well tolerated by 15 opioid-dependent pregnant women, with minimal withdrawal symptoms and negligible illicit opioid use, indicating its safety for maternal use during pregnancy.

The incidence of neonatal abstinence syndrome (NAS) was low, with most neonates showing no symptoms or only mild symptoms, suggesting that buprenorphine is effective in managing opioid dependence in pregnant women without significant risks to the fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of opioid-dependent pregnant women with buprenorphine. Fischer, G., Johnson, RE., Eder, H., et al.[2019]

The Early Start prenatal substance abuse treatment program significantly improved perinatal outcomes for women who were treated, showing lower rates of preterm delivery, placental abruption, and intrauterine fetal demise compared to those who were screened positive but not treated.

Among the 49,985 women studied, those who received treatment (2073 women) had outcomes similar to or better than those who screened negative, highlighting the effectiveness of integrating substance abuse treatment with prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance abuse treatment linked with prenatal visits improves perinatal outcomes: a new standard. Goler, NC., Armstrong, MA., Taillac, CJ., et al.[2019]

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.

Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]

The Parent-Child Assistance Program (PCAP) in Australia showed significant improvements in addiction severity among participants, with 80% achieving periods of abstinence longer than four months and no subsequent alcohol-exposed pregnancies.

Participants reported high satisfaction with the program, and four women successfully had their children returned to their care, indicating positive outcomes for both mothers and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurturing families: One year pilot outcomes for a modified Parent Child Assistance Program in Australia. Symons, M., Finlay-Jones, A., Meehan, J., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05814575/nexus-next-generation-health-through-2d-3d-fetal-ultrasound-building-connections-to-support-maternal-fetal-health

Next Generation Health Through 2D & 3D Fetal UltraSound ... This study will test a community-informed and community-based intervention using a fetal ultrasound protocol, motivational interviewing ...

2. app.dimensions.ai app.dimensions.ai/details/grant/grant.12970065

An approach to engaging pregnant women with substance ... Fetal ultrasound imaging has emerged as a potential tool in the promotion of mental-fetal connection, linked to enhanced engagement in prenatal care and SUD ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573943/

Effects of Recreational Therapy and 3D Ultrasonography ... Intervention with either recreational therapy or 3D ultrasound can prevent the development of mild and major depression and decrease anxiety disorders.

4. vcuhealth.org vcuhealth.org/news/vcu-researchers-have-found-a-new-tool-to-encourage-pregnant-women-to-seek-treatment-for-substance-abuse-disorders/

VCU researchers have found a new tool to encourage ... By building stronger bonds with their unborn baby, VCU researchers say ultrasounds can improve prenatal care and mitigate maternal mortality risks.

5. academic.oup.com academic.oup.com/pnasnexus/article/3/1/pgae003/7591617

Prenatal substance exposure and child health: Understanding ... This study illuminates the health associations of prenatal substance exposure (PSE) in children from age 10 to 12, considering environmental and genetic ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/75/NCT05814575/ICF_000.pdf

National Institute on Drug Abuse (NIDA) / “NEXUS The purpose of this research study is to determine if fetal ultrasound observations can help pregnant persons to feel more connected to babies and if these ...

7. reporter.nih.gov reporter.nih.gov/project-details/10709656

Community-based fetal ultrasound and care navigation We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. aetna.com aetna.com/cpb/medical/data/100_199/0199.html

Ultrasound for Pregnancy - Medical Clinical Policy Bulletins Three-dimensional ultrasound appears to have been useful in research on fetal embryology. However, there is no evidence that the results of 3D ultrasound alters ...