Clinical trial NCT05814575: NEXUS - Next Generation Health Through 2D & 3D Fetal UltraSound; Building Connections to Support Maternal-fetal Health
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Substance Use
Mental Health Issue
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Study Retention
timeFrame: 10-26 weeks
measure: Parent Subjective Connection to Fetus/Infant
timeFrame: Baseline through 12 Weeks post-delivery
measure: Prenatal care utilization
timeFrame: Immediately following infant birth
measure: Substance use treatment utilization
timeFrame: Immediately following infant birth
Secondary outcomes:
measure: Access to Care
timeFrame: 26 weeks
measure: Perceived Stress
timeFrame: 26 weeks
measure: Substance use in pregnancy
timeFrame: Immediately following infant birth
measure: Obstetric complications
timeFrame: 12 weeks postpartum
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References: