JMIR Publications

ABSTRACT

Background:

Substance use may increase risk for adverse health conditions and perinatal complications, and women with substance use disorder (SUD) have a disproportionately higher risk for maternal morbidity and mortality. Fetal ultrasound observations may create an opportunity to increase maternal attachment to the fetus, contributing to greater self-efficacy and self-care through sustained prenatal care and SUD treatment, ultimately improving health outcomes.

Objective:

This pilot sequential explanatory mixed-methods randomized controlled trial was designed to determine the feasibility, acceptability, and efficacy of a novel non-diagnostic fetal ultrasound protocol that promotes maternal-fetal connection in pregnant women with active SUD or high risk of SUD prior to 32 weeks of pregnancy by testing: (1) the feasibility and acceptability of the NEXt generation health through 2D & 3D fetal UltraSound (NEXUS) ultrasound intervention, (2) preliminary group effects on measures of prenatal visit and SUD treatment engagement, gestational age at entry to care, maternal mental health, reported substance use, obstetric outcomes, and maternal-fetal/infant attachment at baseline, two pregnancy visits, and two postpartum visits; and (3) additional factors related to the implementation of the comparator and the NEXUS intervention group activities.

Methods:

After completing baseline measures, participants were randomized to two ultrasound sessions in either a Comparator group (standardized fetal ultrasound sessions controlling for time and attention) or the NEXUS group (interactive fetal ultrasound enhanced with motivational dialogue focusing on fetal behaviors, fetal strengths, and the woman's role in supporting those strengths through self-care). Follow-up surveys and interviews were conducted through 12 weeks postpartum, and a standardized infant neurobehavioral examination was conducted at 6-8 weeks post-birth.

Results:

Funding began in August 2022, with community engagement efforts from January to May 2023 to understand community needs and gather stakeholder input on study integration. Participant enrollment occurred from June 2023 to June 2025. N=141 pregnant individuals were screened for study eligibility, n=122 (86.5%) met study inclusion criteria, n=64 (52.5% of eligible) ultimately enrolled, and n=56 (87.5% of enrolled) were randomized to a study group (n=28 in NEXUS group, 28 in comparator). Follow-up data were then collected for the remaining active participants.

Conclusions:

This paper describes the protocol and enrollment statistics. This study has the potential to improve public health by investigating the feasibility and efficacy of an intervention combining motivational interviewing and ultrasound to promote maternal-fetal attachment and motivation for self-care in pregnant women at high risk for SUD. Findings will identify feasible and acceptable intervention components, provide initial efficacy data, and inform the application of this approach in clinical settings to enhance maternal and child health outcomes. Clinical Trial: Clinicaltrials.gov; NCT05814575