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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的不育和自发流产（SAB）是重要的公共卫生问题，影响多达20％生殖年龄夫妇。随着夫妻越来越多地推迟到后来的生殖年份寻求不育治疗，成功率相对较低，每年估计要花5亿美元美国，与不良妊娠结局有关。应付不育的压力在受影响的夫妇中确切了可衡量的情绪损失。确定不育和SAB的可修改风险因素是重要的公共卫生目标。众所周知，计划怀孕的夫妇很难招募研究使用传统方法的研究。我们已经表明，预入和随访通过北美和丹麦的Internet伴侣的构想伴侣是可行的，有效和成本效益的。我们建议在丹麦的三个相互关联的前瞻性统一队列研究中协调数据（Snart Gratid和Snart Foraeldre）和北美（Presto），以评估选定的饮食因素是否药物会影响女性和男性繁殖力，并影响SAB风险。为了提高我们的统计能力完成这些目标，我们将使用现有的基于NICHD的基于Web的基础架构来收集其他来自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尽管由于生殖年龄的夫妇在使用药物的使用增加而导致的潜在巨大风险。此外，关于饮食因素和最佳设计的繁殖的研究很少对夫妻的研究积极试图受孕。感兴趣的饮食因素包括高血糖负荷/指数，大豆，雌性中的鱼/海鲜，雄性，红色和加工的肉类，乳制品和反式酸性酸。最多 TTP和SAB的研究在设计方面是回顾性的，容易出现错误分类，左截断和选择并回忆起偏见。 TTP和SAB的现有前瞻性研究很小，功能不足。这与类似设计的大型先入后人群的统一将提供出色的能力来评估广泛的假设。在怀孕尝试开始时招募夫妇可以识别关键的窗户暴露易感性。使用社交媒体和与健康相关的网站招聘具有创新性，并且相对于传统方法，极其成本效益。包括男性是创新的，因为它允许评估两个伴侣暴露的个人和关节影响，并允许更好地控制混淆。注册表数据的利用将使额外的暴露和结果数据，数据，数据验证，识别失去随访的人以及评估选择偏差和概括性。这将是TTP和SAB的可修改风险因素的最大前瞻性预选人群研究日期。拟议研究的发现可能会对该领域产生巨大的影响，并将为夫妻提高了提高生育能力并降低其SAB风险的可行建议。