Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies.

产前酒精暴露（PAE）会增加胎儿酒精谱系障碍的风险， 身体、认知、运动和神经发育迟缓。在我们的美国进行的一项试点研究（N=318）中，Rusian 伊尔库茨克地区妇产医院（RMH）的一个研究小组发现，59%的女性酒精检测呈阳性 通过实验室确认的酒精生物标志物（PEth）进行评估。拟议的研究将采用一种有效的 在俄罗斯非怀孕饮酒妇女中评估酒精减少干预，以优化其 产前护理中使用酒精的妇女的疗效。我们建议实施一项随机对照试验 （N=720），以评估减少饮酒干预相对于标准治疗在以下方面的疗效：（1）减少 产前护理中孕妇的酒精消费，2）减少不良生育结果，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。我们将招募妇女在他们的第一次产前访问伊尔库茨克RMH。符合条件的妇女（1）年龄在18岁以上; (2)提供知情同意书;（3）近期饮酒的快速床旁尿液检测呈阳性;（4）≤8 妊娠10周完成基线评估。女性被随机分为两种情况： 干预条件，包括标准治疗加酒精减少干预，或比较 条件，仅提供护理标准。在酒精减少干预中，参与者获得：（1）a 计算机提供的组成部分，以提高知识，规范和动机，减少酒精，和（2）一个 简短的产科医生提供的组成部分，加强计算机提供的内容。醇减少 干预是理论驱动的，并使用动机增强战略，以促进减少酒精。的 在三种情况下向妇女提供减少酒精的干预措施，在基线之后，第二个三个月， 和第三季度评估。处于比较条件下的女性完成了对相同 schedule.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，所有母亲返回 与他们的婴儿一起完成6个月和12个月婴儿评估。意向治疗分析评估了 干预条件相对于比较条件在提高妇女比例方面的效力 经实验室确认为阴性的PEth检测。其他分析评估干预对出生的影响 结果，婴儿的身体和面部特征，以及6岁时的认知、运动和发育结果。 和12个月。该研究具有科学和临床意义。如果证明有效， 干预措施可能是其他妇产医院产前护理的可扩展酒精减少策略， 俄罗斯和其他地方，以减少产前酒精暴露和与酒精有关的出生和婴儿发育 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.