Smoking cessation intervention for Indigenous pregnant women: A systematic review of randomized controlled trials

To synthesize evidence on smoking cessation interventions among pregnant Indigenous women. We conducted a systematic search of databases from inception (MEDLINE, 1946; Embase, 1947; CENTRAL, 1991; APA PsycINFO, 1806; Informit Indigenous Collection, 1977; Bibliography of Indigenous Peoples in North America, 1900; and Global Health, 1973) to May 28, 2025. Eligible studies included trials targeting smoking or vaping cessation among pregnant Indigenous women. Interventions at the individual or community level were eligible, including education, counseling, pharmacotherapy, incentives, biomarker feedback, digital health, or community-based programs. Of 5534 studies screened, five studies involving 723 pregnant Indigenous women from Australia, New Zealand, and the United States met inclusion. Validated cessation rates were low, rarely exceeding 20% across interventions. Three studies reported improvements in quit attempts and quit-date setting. All interventions were feasible and acceptable, particularly those embedded within Indigenous health services. Facilitators included Indigenous leadership, provider training, and use of culturally relevant materials, whereas low recruitment (32%) and retention rates (<40%), staff turnover, and variable intervention fidelity were barriers to intervention implementation. Evidence suggests that although culturally adapted smoking cessation interventions are feasible, they have not consistently improved abstinence rates among pregnant Indigenous women, reflecting broader structural and contextual barriers. • Five trials have evaluated cessation interventions in pregnant Indigenous women. • Culturally adapted interventions improved quit attempts but not sustained abstinence. • High attrition and implementation challenges limited intervention effectiveness. • Evidence gaps persist for Indigenous populations in Canada and the United States. • System and community-level approaches are needed to address structural barriers.