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.

抽象的 不孕不育和自然流产 (SAB) 是重要的公共卫生问题，影响高达 20% 的人口 育龄夫妇。随着越来越多的夫妇将生育推迟到育龄后期，许多人 寻求不孕不育治疗的成功率相对较低，每年估计花费 50 亿美元 美国，并与不良妊娠结局相关。还应对不孕的压力 对受影响的夫妇造成了可衡量的情感损失。识别不孕症和 SAB 的可改变风险因素 是一项重要的公共卫生目标。众所周知，计划怀孕的夫妇很难招募到 使用传统方法进行研究。我们已经表明，预登记和后续行动 在北美和丹麦通过互联网受孕夫妇是可行、有效且具有成本效益的。 我们建议协调丹麦三项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）评估是否选择了饮食因素 药物会影响女性和男性的生育能力以及 SAB 风险。为了提高我们的统计能力 为了实现这些目标，我们将使用现有的 NICHD 支持的基于网络的基础设施来收集更多 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 抗生素、哮喘药物、抗抑郁药和镇痛药等药物会影响生育能力和 SAB，尽管 由于育龄夫妇越来越多地使用药物，潜在的巨大归因风险。 此外，关于饮食因素和最佳设计队列的繁殖的研究也很少 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、 女性喜欢吃鱼/海鲜，男性喜欢吃红肉和加工肉类、乳制品和反式脂肪酸。最多 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 和回忆偏见。现有的少数 TTP 和 SAB 前瞻性研究规模较小且动力不足。这 具有类似设计的大型先入为主群体的协调将为评估 广泛的假设。在夫妇尝试怀孕之初就进行登记可以确定关键窗口期 的暴露敏感性。使用社交媒体和健康相关网站进行招聘具有创新性和 相对于传统方法极具成本效益。将男性纳入其中是创新的，因为它允许 评估双方暴露的个体和联合影响，并允许更好地控制 令人困惑。注册数据的利用将能够收集额外的暴露和结果数据、数据 验证、识别失访者以及评估选择偏倚和普遍性。这 将是针对 TTP 和 SAB 可改变危险因素的最大前瞻性孕前队列研究 日期。拟议研究的结果可能对该领域产生巨大且持续的影响，并将 为夫妇提出切实可行的建议，以提高生育能力并降低 SAB 风险。