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

Pregnancy Related Clinical Trial

— NEXUS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814575
• Other study ID #: HM20025280
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: Andrea Publow
• Phone: 804-828-6772
• Email: dirospa[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Health Issue
• Pregnancy Related
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• NEXUS intervention
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 ultrasound
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Retention	Percentage of each group returning for a second study visit	10-26 weeks
Primary	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
Primary	Prenatal care utilization	The number of prenatal care visits per week of gestation at delivery.	Immediately following infant birth
Primary	Substance use treatment utilization	The number of substance use/mental health treatment visits per week of gestation at delivery.	Immediately following infant birth
Secondary	Access to Care	PRAMS access to care survey	26 weeks
Secondary	Perceived Stress	Perceived Stress Scale	26 weeks
Secondary	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).	Immediately following infant birth
Secondary	Obstetric complications	The total number of Obstetrics Complications identified by participant reports and medical record occurring from pregnancy through 12 weeks postpartum.	12 weeks postpartum