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Safe start, a hybrid intervention to reduce alcohol exposed pregnancies: protocol for a randomized controlled trial
Ariadna Capasso1, Angela L Stotts2, Mia Ann Xu3
1Health Resources in Action, Boston, MA, USA. acapasso@hria.org.
Insights
This study tested Safe Start, a digital and nurse-led intervention to reduce alcohol-exposed pregnancies. The intervention aims to decrease fetal alcohol spectrum disorders (FASD) and improve birth outcomes.
Area of Science:
- Obstetrics and Gynecology
- Public Health
- Maternal-Fetal Medicine
Background:
- Prenatal alcohol exposure (PAE) leads to fetal alcohol spectrum disorders (FASD) and adverse birth outcomes.
- PAE remains prevalent in the U.S., with 13.5% of pregnant women reporting alcohol use.
- Current interventions show mixed results due to healthcare provider workload and limited visit times.
Purpose of the Study:
- To evaluate the efficacy of the Safe Start hybrid intervention in reducing alcohol-exposed pregnancies.
- To assess the intervention's impact on laboratory-confirmed alcohol use and adverse birth outcomes.
Main Methods:
- A randomized controlled trial involving pregnant women (18+ years, <28 weeks gestation) reporting recent alcohol use.
- Participants were randomized to Safe Start (digital + nurse sessions) or usual prenatal care.
- Efficacy was measured by negative phosphatidylethanol levels (biomarker for alcohol use) and adverse birth outcomes using intent-to-treat analysis.
Main Results:
- The study is ongoing; results are pending.
- The intervention is designed to be delivered over three visits, integrating digital and nurse-led sessions.
- The primary outcome is the proportion of women with a laboratory-confirmed negative phosphatidylethanol at each visit.
Conclusions:
- The Safe Start intervention, if effective, could be a scalable strategy for maternity care in the U.S.
- It aims to reduce PAE and alcohol-related adverse birth outcomes, including FASD.
- The intervention is being tested in an urban clinic serving primarily low-income, minority women.
Background:
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.
Methods:
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).
Discussion:
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.
Trial Registration:
The study is registered on clinicaltrials.org; Clinical Trials Registration Number: NCT05766761; Registration Date: 2023-02-27.
