Building the mountain mama & baby cohort: study design, protocol, and early prenatal clinic-based recruitment outcomes
Clinical Snapshot
PICO Framework
| P — Population | Pregnant women in first trimester receiving care at West Virginia University Medicine obstetric clinics |
| I — Intervention | Prospective cohort enrollment during initial telehealth visits with nurse navigators |
| C — Comparator | Not applicable (cohort study design) |
| O — Outcomes | Recruitment feasibility, sample representativeness, and future assessment of prenatal e-cigarette and cannabis exposure effects on maternal-infant outcomes |
Bottom Line
The Mountain Mama & Baby Study represents a well-designed protocol for investigating prenatal e-cigarette and cannabis exposure effects. The 45.3% recruitment rate demonstrates feasibility of telehealth-based enrollment, with good sample representativeness across sociodemographic factors. However, this is a protocol paper without outcome data, limiting current clinical utility. The single-centre West Virginia setting may limit generalizability to other populations. While the research question addresses an important clinical gap regarding emerging prenatal exposures, clinicians must await actual results before drawing conclusions about e-cigarette and cannabis safety in pregnancy. The telehealth recruitment methodology could inform future pregnancy research design, particularly relevant in post-pandemic healthcare delivery models.
Key Findings
Effect Size: 45.3% recruitment rate
Primary Outcome: Recruitment feasibility and sample representativeness
Nnt Or Sensitivity: Recruitment rate exceeded 20% benchmark by 2.3-fold
Confidence Interval: 95% CI: 42.1% to 48.6%
Clinical Application
Telehealth recruitment model appears feasible and could be adapted to other healthcare systems Methodology could inform Australian pregnancy cohorts; findings may be relevant given similar e-cigarette and cannabis use trends, though population differences limit direct applicability Pregnant women in first trimester, particularly those with potential e-cigarette or cannabis exposure
Abstract
Prenatal e-cigarette and cannabis use are increasing. Though concerning, the risks associated with these emerging exposures are unclear due to methodological limitations of available research. To address these gaps, the Mountain Mama & Baby Study prospectively enrolled a cohort of pregnant women in their first trimester during their initial telehealth visit with a nurse navigator at West Virginia University Medicine obstetric clinics. The study's goals were to (1) demonstrate the feasibility of our recruitment methodology and the representativeness of the sample, (2) establish first and third trimester exposure rates and describe the epidemiology of prenatal e-cigarette and cannabis use, and (3) explore associations between prenatal e-cigarette and cannabis exposure and adverse maternal-infant outcomes. This report describes the rationale, study design, protocol, and the feasibility and generalizability of recruitment. We enrolled 417 of 920 eligible participants (45.3%; 95% CI, 42.1% to 48.6%), exceeding our 20% benchmark. Enrolled participants and those nonenrolled were similar across most sociodemographic characteristics (eg, age, race/ethnicity, marital status, rurality, area deprivation). The Mountain Mama & Baby Study will provide clinicians, pregnant women, and public health practitioners with critical information on the potential harms of prenatal e-cigarette and cannabis use, guiding the design of interventions and recommendations.
References
- 1.Barone Gibbs, B., Chmelik, K., Marshall, E. M., Henggeler, W. K., Olfert, I. M., Rowan, S., Lilly, C., Hodder, S. L., & Umer, A. (2026). Building the mountain mama & baby cohort: study design, protocol, and early prenatal clinic-based recruitment outcomes. American Journal of Epidemiology. https://doi.org/10.1111/add.14651
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