An internet-based preconception cohort study in North America and Denmark

北美和丹麦基于互联网的孕前队列研究

• 批准号: 9982084
• 负责人: ELIZABETH E HATCH
• 金额: $ 56.33万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-14 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982084
• 关键词: Affect; Age; Analgesics; Antibiotics; Antidepressive Agents; Anxiety; Asthma; Carbohydrates; Child; Cohort Studies; Collection; Conceptions; Consumption; Couples; Data; Delayed Childbearing; Denmark; Diet; Dietary Factors; Dietary Practices; Economic Burden; Emotional; Enrollment; Fatty acid glycerol esters; Female; Fertility; Fiber; Fishes; Food; Funding; Gravid; Health; Healthy Eating; Individual; Infant; Infertility; Infrastructure; Intake; Internet; Joints; Left; Link; Maternal Age; Measurable; Mental Depression; Methods; Mothers; National Institute of Child Health and Human Development; Non-Steroidal Anti-Inflammatory Agents; North America; Omega-3 Fatty Acids; Online Systems; Outcome; Patient Self-Report; Pattern; Pharmaceutical Preparations; Phytoestrogens; Predisposition; Pregnancy; Processed Meats; Prospective Studies; Prospective cohort study; Public Health; Recommendation; Reproduction; Research; Resources; Risk; Risk Factors; Seafood; Selection Bias; Services; Shellfish; Spontaneous abortion; Stress; Time Factors; Trans Fatty Acids; Treatment Effectiveness; United States; Validation; Woman; adverse pregnancy outcome; aged; base; child bearing; cohort; coping; cost; cost effective; cost efficient; cost estimate; data harmonization; data registry; design; early pregnancy; experience; follow up assessment; follow-up; health goals; high risk; improved; indexing; infertility treatment; innovation; interest; male; modifiable risk; pregnant; prospective; psychologic; recruit; red meat consumption; reproductive; research study; social media; soy; subfertility; success; time-to-pregnancy; trying to conceive; web site

ABSTRACT Infertility and spontaneous abortion (SAB) are important public health problems, affecting up to 20% of reproductive age couples. As couples increasingly postpone childbearing to the later reproductive years, many seek infertility treatment, which has relatively low success rates, costs an estimated $5 billion per year in the United States, and is associated with adverse pregnancy outcomes. Coping with the stress of infertility also exacts a measurable emotional toll in affected couples. Identifying modifiable risk factors for infertility and SAB is an important public health goal. Couples planning a pregnancy are notoriously difficult to recruit into research studies using traditional methods. We have shown that enrollment and follow-up of pre- conception couples via the internet in North America and Denmark is feasible, valid, and cost-efficient. We propose to harmonize data from three interrelated prospective preconception cohort studies in Denmark (Snart Gravid and Snart Foraeldre) and North America (PRESTO) to evaluate whether selected dietary factors and medications influence female and male fecundity, and SAB risk. In order to increase our statistical power to accomplish these aims, we will use our existing NICHD-supported web-based infrastructure to collect additional data from 6,000 females and 2,000 of their male partners. There is limited evidence on whether commonly-used medications, such as antibiotics, asthma drugs, antidepressants, and analgesics affect fertility and SAB, despite the potentially large attributable risk due to increasing use of medications among couples of reproductive age. In addition, there is a scarcity of research on dietary factors and reproduction from optimally-designed cohort studies of couples actively trying to conceive. Dietary factors of interest include high glycemic load/index, soy, and fish/seafood among females and red and processed meats, dairy, and trans-fatty acids among males. Most studies of TTP and SAB are retrospective in design and prone to misclassification, left truncation, and selection and recall biases. The few existing prospective studies of TTP and SAB are small and underpowered. The harmonization of large preconception cohorts with similar designs will provide excellent power to evaluate a broad range of hypotheses. Enrolling couples at the start of their pregnancy attempt can identify critical windows of exposure susceptibility. The use of social media and health-related websites for recruitment is innovative and extremely cost-effective relative to traditional methods. Inclusion of males is innovative because it allows for the assessment of individual and joint effects of exposures in both partners, and permits better control for confounding. Utilization of registry data will enable the collection of additional exposure and outcome data, data validation, identification of those lost to follow-up, and assessment of selection bias and generalizability. This will be the largest prospective preconception cohort study of modifiable risk factors for TTP and SAB to date. Findings from the proposed research are likely to have a large and sustained impact on the field and will result in actionable recommendations for couples to improve their fertility and lower their risk of SAB.

摘要 不孕症和自然流产（SAB）是重要的公共卫生问题，影响到多达20%的 育龄夫妇随着越来越多的夫妇将生育推迟到生育年龄后期， 寻求成功率相对较低的不孕症治疗，估计每年花费50亿美元， 美国，并与不良妊娠结局相关。应对不孕症的压力也 对受影响的夫妇造成了可衡量的情感损失。确定不孕症和SAB的可改变风险因素 是一个重要的公共卫生目标。计划怀孕的夫妇是出了名的难以招募到 使用传统方法进行研究。我们已经表明，登记和随访的前- 在北美和丹麦，通过互联网对夫妇进行受孕是可行的、有效的、具有成本效益的。 我们建议协调来自丹麦三个相互关联的前瞻性孕前队列研究的数据 （Snart Gravid和Snart Foraeldre）和北美（PRESTO），以评估所选饮食因素是否 和药物影响女性和男性的生育力，和SAB风险。为了提高我们的统计能力， 为了实现这些目标，我们将利用现有的NICHD支持的基于网络的基础设施， 来自6,000名女性和2,000名男性伴侣的数据。关于是否常用的证据有限 药物，如抗生素，哮喘药，抗抑郁药和镇痛药影响生育能力和SAB，尽管 由于育龄夫妇使用药物的增加，潜在的巨大可归因风险。 另外，从最优设计队列研究膳食因素与繁殖的关系也较少 对积极尝试怀孕的夫妇的研究。感兴趣的饮食因素包括高血糖负荷/指数，大豆， 女性中的鱼类/海鲜，男性中的红色和加工肉类，乳制品和反式脂肪酸。最 TTP和SAB的研究在设计上是回顾性的，容易出现错误分类、左截断和选择 和回忆偏差现有的TTP和SAB的几项前瞻性研究规模较小且效力不足。的 具有类似设计的大型孕前队列的协调将提供极好的功效来评估 广泛的假设。在怀孕尝试开始时登记夫妇可以确定关键窗口 暴露敏感性的影响。利用社交媒体和卫生相关网站进行征聘是一种创新， 相对于传统方法来说，这是一种非常经济的方法。将男性包括在内是一种创新，因为它允许 评估暴露对双方的个体和联合影响，并允许更好地控制 真让人困惑利用登记数据将能够收集额外的暴露和结局数据， 验证、识别失访者、评估选择偏倚和可推广性。这 将是最大的前瞻性孕前队列研究，研究TTP和SAB的可改变风险因素， 约会拟议研究的结果可能会对该领域产生巨大而持续的影响， 为夫妇提供可操作的建议，以提高他们的生育能力并降低SAB的风险。