Black Pregnant and Postpartum Peoples' Perspectives on Mental Health and Substance Use Disorders.

Introduction: Mental health and substance use disorders in pregnant and postpartum people (PPP) are common, and most will not receive adequate treatment. In addition, Black PPP experience higher rates of mental health conditions and are less likely to receive treatment compared with White PPP. Yet, our understanding of the experience of Black PPP with respect to these conditions is limited. The goal of this study was to better understand these experiences with respect to mental health, substance use, and barriers to treatment. Methods: Semi-structured interviews were completed with 68 Black PPP who were pregnant or had been pregnant in the last 24 months to gain an understanding of mental health and substance use screening and treatment during the peripartum and postpartum period. Interview data were analyzed with qualitative software, using a qualitative content analysis method, informed by grounded theory. Results: Four main themes were identified: (1) personal beliefs and views about mental health and substance use, (2) family and community beliefs about mental health and substance use, (3) personal experience with mental health and substance use, and (4) comfort in talking to others about mental health and substance use. Subthemes evolved within each of the four themes. Black PPP indicated that maternal mental health and substance use disorders are common in the Black community, but negative stigma related to these conditions often prevents PPP from talking about these conditions or seeking support or treatment despite believing that support and treatment can be beneficial. Conclusions: Clinical practice initiatives within this population can focus on advanced training for providers to more clearly understand personal experiences and related stigma related to mental health and substance use disorders, with the goal of supporting Black PPP mental health needs.

Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.

Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.

The Safety of Mother's Milk® Tea: Results of a Randomized Double-Blind, Controlled Study in Fully Breastfeeding Mothers and Their Infants.

BACKGROUND: Various natural products are reported to improve maternal milk supply yet are not necessarily safe for infants. Researchers have not systematically studied galactagogue teas for safety. RESEARCH AIM: This study evaluates the safety of a galactagogue tea in breastfeeding women and their infants, assessing short- and long-term adverse effects. METHODS: Healthy, exclusively/fully breastfeeding women ( N = 60) with no milk insufficiency were randomized into (1) an all-natural tea containing fruits of bitter fennel, anise, and coriander; fenugreek seed; and other herbs (Mother's Milk® herbal tea; test) group or (2) a lemon verbena leaf (placebo) group. Maternal diaries captured self-reported maternal and infant adverse effects, tea consumed, and perceived infant satisfaction. Maternal quality of life and psychological state were assessed at baseline and 2 and 4 weeks. Poststudy calls assessed adverse effects through the infants' age of 12 months. RESULTS: No adverse effects attributable to the interventions were reported at any time point. No differences were found between test and placebo groups in sociodemographic characteristics, maternal or infant adverse symptoms, quality of life, breastfeeding self-efficacy, maternal psychological measures, infant growth, and infant satisfaction (all p >.05). CONCLUSIONS: This double-blind, randomized controlled trial (RCT) of an herbal galactagogue versus placebo among healthy, exclusively/fully breastfeeding mothers and infants found no adverse events associated with the test tea across the 30-day study or the first year of their infant's life. This composite tea appears to present no safety risk for mothers or their young babies.