Safe start, a hybrid intervention to reduce alcohol exposed pregnancies: protocol for a randomized controlled trial

Prenatal alcohol exposure (PAE) increases the risk for serious adverse birth outcomes and long-term neurodevelopmental, physical, and mental health outcomes, known under the umbrella term of fetal alcohol spectrum disorders (FASD). Despite its well-documented adverse effects, PAE continues to be prevalent in the United States (U.S.), where an estimated 13.5% of women report alcohol consumption during pregnancy. Brief interventions to reduce PAE delivered during prenatal care have obtained mixed results, in part due to obstetricians' high workload and short prenatal care visits. To overcome this challenge and address the need, Safe Start is a clinical trial to evaluate the efficacy of a hybrid intervention to reduce alcohol-exposed pregnancies delivered on a digital platform and by prenatal care nurses.

Women attending obstetrics clinics for pregnancy confirmation or an initial prenatal care visit are screened for eligibility. To qualify, participants must be at least 18 years old; have a gestational age of less than 28 weeks; report any alcohol use in the past 30 days; and provide consent to participate. Recruited participants are randomized in 1:1 proportion to the Safe Start intervention plus usual prenatal care or usual prenatal care alone. Over three visits, participants receive two digitally- and three nurse-delivered sessions based on motivational enhancement principles. Sessions are scheduled during prenatal care appointments to minimize participant burden and increase retention. Using an intent-to-treat analysis, weighted generalized estimating equations will be used to evaluate the intervention's efficacy, relative to usual care, in enhancing the proportion of women with a laboratory-confirmed negative phosphatidylethanol, a biomarker for alcohol use, at each visit. Additional analyses will evaluate intervention effects on the prevalence of adverse birth outcomes (preterm birth and low birth weight).

This intervention is embedded within a prenatal care clinic in a large urban setting serving primarily low-income racially minoritized women. If efficacious, this theory-driven, rigorously tested intervention may represent a scalable strategy suitable for adoption in maternity care across the U.S. to reduce PAE and alcohol-related adverse birth outcomes, including FASD.

The study is registered on clinicaltrials.org; Clinical Trials Registration Number: NCT05766761; Registration Date: 2023-02-27.