An internet-based preconception cohort study in North America

北美基于互联网的孕前队列研究

• 批准号: 10521733
• 负责人: LAUREN A WISE
• 金额: $ 70.88万
• 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 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10521733
• 关键词: 3-Dimensional; Acute; Adult; Affect; American; Area; Assisted Reproductive Technology; Biological Markers; Black race; Buffers; Child; Chronic; Cohort Studies; Collection; Conceptions; Couples; Data; Discrimination; Emotional; Enrollment; Ensure; Etiology; Female; Financial Hardship; Geography; Hair; Health Care Costs; Health Services Accessibility; Heterogeneity; Hour; Hydrocortisone; Indigenous; Individual; Infertility; Infrastructure; Internet; Intervention; Joints; Life; Life Cycle Stages; Low income; Measures; Mediating; National Institute of Child Health and Human Development; North America; Occupational; Occupations; Online Systems; Outcome; Participant; Patient Recruitments; Patient Self-Report; Perinatal; Physiological; Pilot Projects; Pittsburgh Sleep Quality Index; Play; Population; Pregnancy; Pregnancy loss; Prospective Studies; Prospective cohort; Prospective cohort study; Public Health; Race; Reproductive Health; Research; Risk; Risk Factors; Role; Salivary; Selection Bias; Sleep; Sleep Fragmentations; Social support; Spontaneous abortion; Stratification; Stress; Teenagers; Underrepresented Populations; United States; Woman; Work; actigraphy; adverse childhood events; aged; alpha-amylase; base; childhood adversity; coronavirus disease; cost; cost efficient; design; ethnic disparity; experience; fitbit; follow-up; health goals; high risk; infertility treatment; male; men; modifiable risk; novel; occupational stressor; people of color; perceived stress; perinatal outcomes; poor sleep; public health intervention; racial and ethnic; racial and ethnic disparities; racial discrimination; racial disparity; racism; recruit; reproductive; reproductive outcome; shift work; sleep health; sleep onset; sleep pattern; sleep quality; stressor; subfertility; success; time-to-pregnancy; treatment disparity

ABSTRACT About 15% of American couples experience infertility (time-to-pregnancy >12 months) and more than 20% of couples experience spontaneous abortion (SAB, pregnancy loss <20 weeks of gestation). Fertility treatment is costly and inaccessible to most Americans, particularly people of color and low-income individuals. Among those with access to treatment, fertility treatment has relatively low success rates and is associated with adverse perinatal outcomes. There are also large racial/ethnic disparities in treatment success rates. As infertility and SAB exact an emotional and financial toll on affected couples, identifying modifiable risk factors for these outcomes in both partners is an important public health goal. With previous support from the NICHD, we designed a web-based prospective cohort study to recruit, follow, and collect comprehensive data on couples attempting pregnancy. Some of our strongest findings to date pertain to poor sleep quality and stress in both partners. To build on this work, we are submitting a renewal application (R01-HD086742) to evaluate the influence of understudied sleep- and stress-related exposures on subfertility and SAB risk, explore putative mechanisms of effect, and examine the extent to which these factors explain existing race/ethnic disparities in subfertility and SAB. Pregnancy Study Online (PRESTO) is a web-based preconception cohort study in North America that has enrolled more than 16,000 females and nearly 4,000 male partners during the preconception period, with 20% of PRESTO participants identifying as Black, Indigenous, or People of Color (BIPOC). In this renewal application, we propose to enroll an additional 8,000 females to enhance power for more detailed analyses of sleep using the Pittsburgh Sleep Quality Index, selected stressors (e.g., childhood adversity, discrimination, financial hardship, COVID-related factors), and risk of subfertility and SAB. We also propose to collect and analyze more objective exposure data using sleep actigraphy (Fitbit Inspire 2) and stress biomarkers (hair cortisol and salivary alpha-amylase) in a subset of new participants. We will enroll an additional 2,000 male partners to enhance power for examining male exposures and joint effects in both partners. To ensure power for key hypotheses (e.g., reproductive effects of racial discrimination), we will oversample BIPOC participants. This renewal application builds on our previous work indicating that stress and sleep quality are important determinants of reproductive health. Our expanded focus on understudied stressors—in populations that are underrepresented in reproductive and perinatal research (e.g., males and BIPOC)—is novel and of high public health importance. Preconception enrollment minimizes misclassification, selection bias, and reverse causation, and captures early SABs (<8 weeks of gestation), a priority area for NICHD. The cohort’s prospective design, cost-efficient web- based infrastructure for participant recruitment and follow-up, geographic and racial/ethnic heterogeneity, and comprehensive collection of confounder data in both partners are added strengths. Results will generate data that can inform public health interventions to reduce the population burden of subfertility and SAB.

摘要 大约15%的美国夫妇经历不孕不育(怀孕12个月)，超过20%的夫妇 夫妇经历自然流产(SAB，妊娠丢失和妊娠20周)。生育治疗是 价格昂贵，大多数美国人，特别是有色人种和低收入个人负担不起。其中包括 在获得治疗的情况下，生育治疗的成功率相对较低，并与不利的 围产儿结局。在治疗成功率方面也存在很大的种族/族裔差异。作为不孕不育和 SAB对受影响的夫妇造成情感和经济损失，确定这些因素的可修改风险因素 这两个伙伴的结果是一个重要的公共卫生目标。在NICHD之前的支持下，我们设计了 一项基于网络的前瞻性队列研究，旨在招募、跟踪和收集有关尝试 怀孕了。到目前为止，我们的一些最有力的发现与双方睡眠质量差和压力有关。至 在此工作的基础上，我们正在提交续订申请(R01-HD086742)，以评估 睡眠和压力相关暴露对不孕不育和SAB风险的研究不足，探索可能的机制 影响，并检查这些因素在多大程度上解释了现有的种族/民族不育和 SAB。在线怀孕研究(Presto)是北美的一项基于网络的先入为主的队列研究，它有 在怀孕前阶段，招募了16,000多名女性和近4,000名男性伴侣，其中20% Presto参与者的身份识别为黑人、土著或有色人种(BIPOC)。在此续签申请中， 我们建议额外招募8,000名女性，以增强对睡眠的更详细分析。 匹兹堡睡眠质量指数，选定的压力源(例如，童年逆境、歧视、经济 艰苦、COVID相关因素)、不孕不育和SAB风险。我们还建议收集和分析更多 使用睡眠活动记录仪(Fitbit Inspire 2)和应激生物标记物(头发、皮质醇和唾液)获得客观暴露数据 α-淀粉酶)在新参与者的子集中。我们将额外招收2000名男性合作伙伴，以增强 检查男性暴露和双方共同影响的权力。确保关键假设的力量 (例如，种族歧视的生殖影响)，我们将对BIPOC参与者进行过度抽样。此次续订 应用程序建立在我们之前工作的基础上，表明压力和睡眠质量是影响睡眠质量的重要因素 生殖健康。我们将重点放在研究不足的压力源上--在代表性不足的人群中 在生殖和围产期研究方面(例如，男性和BIPOC)--是新颖的，对公共卫生具有很高的重要性。 先入为主的登记将错误分类、选择偏差和反向因果关系降至最低，并及早捕获 SABS(妊娠8周)，NICHD的优先领域。该队列的前瞻性设计，成本效益高的网络- 为参与者招募和后续行动、地域和种族/族裔异质性提供基础设施，以及 全面收集双方合作伙伴的混杂数据是更大的优势。结果将生成数据 这可以为公共卫生干预措施提供信息，以减少亚生育率和SAB的人口负担。