Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies.

产前酒精暴露(PAE)增加胎儿酒精谱障碍的风险，对 身体、认知、运动和神经发育迟缓。在我们的美国-俄罗斯人进行的一项试点研究中(N=318) 伊尔库茨克地区妇产医院(RMH)的研究小组发现，59%的女性酒精检测呈阳性 通过实验室确认的酒精生物标记物(PEH)进行评估。拟议的研究将采用一种有效的 俄罗斯对非妊娠饮酒妇女的减酒干预评估以优化其 酒精使用妇女在产前护理中的疗效。我们建议实施一项随机对照试验 (n=720)评估酒精减少干预相对于护理标准在(1)减少 孕妇在产前护理中饮酒，2)减少不良生育结局，3)减少 婴儿与酒精相关的身体和面部特征以及认知、运动和神经发育 结果。我们将在伊尔库茨克RMH的第一次产前访问中招募妇女。符合条件的女性(1)年龄为18岁； (2)提供知情同意；(3)最近饮酒的护理地点尿液快速检测呈阳性；及(4)≤8 妊娠数周完成基线评估。女性被随机分成两种情况之一： 干预条件，包括标准护理加酒精减少干预，或对照 条件，这只提供标准的护理。在戒酒干预中，参与者得到：(1) 计算机提供的组成部分，以增强知识、规范和减少酒精的动机，以及(2) 简要介绍产科医生提供的内容，以加强计算机提供的内容。减少饮酒量 干预是理论驱动的，使用激励增强策略来促进戒酒。这个 在三种情况下对妇女进行减酒干预，在她们的基线、中期妊娠、 和第三个月的评估。处于比较状态的女性完成了对相同的评估 时间表。为了评估婴儿的出生结果，我们将在分娩后不久提取医疗记录。评估 身体和面部特征以及认知、运动和神经发育结果，所有母亲都会回来 与他们的婴儿一起完成6个月和12个月的婴儿评估。意向治疗分析评估 干预条件相对于对照条件对提高妇女比例的效果 用实验室确认的阴性佩斯试验进行检测。其他分析评估对分娩的干预效果 结果，婴儿的身体和面部特征，以及认知、运动和发育结果 还有12个月。本研究具有重要的科学意义和临床意义。如果证明是有效的， 干预措施可能代表着一种可扩展的减少酒精战略，适用于#年其他妇产科医院的产前护理 俄罗斯和其他地方减少产前酒精暴露和酒精相关的分娩和婴儿发育 结果。如果成功，这将是作为CIFASD的一部分进行的第一次预防干预。

Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders, adversely affecting physical, cognitive, motor, and neurodevelopmental delay. In a pilot study (N=318) conducted by our U.S.-Rusian team at the Irkutsk Regional Maternity Hospital (RMH), 59% of women tested positive for alcohol consumption as assessed by a laboratory-confirmed alcohol biomarker (PEth). The proposed study will adapt an effective alcohol reduction intervention evaluated in Russia among non-pregnant alcohol-using women to optimize its efficacy for alcohol-using women in prenatal care. We propose to implement a randomized controlled trial (N=720) to assess the efficacy of the alcohol reduction intervention, relative to standard-of-care, in (1) reducing alcohol consumption among pregnant women in prenatal care, 2) reducing poor birth outcomes, and 3) reducing infants’ alcohol-related physical and facial characteristics, and cognitive, motor and neurodevelopmental outcomes. We will recruit women at their first prenatal visit to the Irkutsk RMH. Eligible women (1) are >18 years; (2) provide informed consent; (3) have a positive rapid point-of-care urine test for recent alcohol use; and (4) ≤8 weeks gestation complete a baseline assessment. Women are randomized to one of two conditions: the intervention condition, which includes standard-of-care plus the alcohol reduction intervention, or the comparison condition, which provides standard-of-care only. In the alcohol reduction intervention, participants receive: (1) a computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction, and (2) a brief obstetrician-delivered component reinforcing the computer-delivered content. The alcohol reduction intervention is theory-driven and uses motivational enhancement strategies to promote alcohol reduction. The alcohol reduction intervention is delivered to women on three occasions, following their baseline, 2nd-trimester, and 3rd-trimester assessments. Women in the comparison condition complete assessments on the same schedule. To assess infant birth outcomes, we will abstract medical records shortly after delivery. To assess physical and facial characteristics and cognitive, motor, and neurodevelopmental outcomes, all mothers return with their infants to complete 6- and 12-month infant assessments. An intent-to-treat analysis evaluates the efficacy of the intervention condition relative to the comparison condition in enhancing the proportion of women detected with a laboratory-confirmed negative PEth test. Other analyses assess intervention effects on birth outcomes, infant physical and facial characteristics, and cognitive, motor, and developmental outcomes at 6- and 12-months. The proposed research is scientifically and clinically significant. If demonstrated effective, the intervention may represent a scalable alcohol reduction strategy for prenatal care in other maternity hospitals in Russia and elsewhere to reduce prenatal alcohol exposure and alcohol-related birth and infant developmental outcomes. If successful, this would be the first prevention intervention conducted as part of CIFASD.