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.

抽象的 大约 15% 的美国夫妇患有不孕症（怀孕时间>12 个月），超过 20% 经历自然流产的夫妇（SAB，怀孕20周以下的妊娠丢失）需要接受生育治疗。 大多数美国人，尤其是有色人种和低收入人群，成本高昂且难以获得。 在获得治疗的情况下，生育治疗的成功率相对较低，并且与不良反应有关 围产期结局也存在巨大的种族/民族差异。 SAB 对受影响的夫妇造成了情感和经济损失，并确定了这些可改变的风险因素 在 NICHD 的先前支持下，我们设计了合作伙伴的成果是一个重要的公共卫生目标。 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的夫妇的综合数据 迄今为止，我们最有力的一些发现与伴侣的睡眠质量和压力有关。 在此工作的基础上，我们正在提交续展申请（R01-HD086742）来评估 未充分研究睡眠和压力相关暴露对生育力低下和 SAB 风险的影响，探索假定的机制 影响，并研究这些因素在多大程度上解释了生育力低下和种族歧视方面现有的种族/民族差异 SAB 在线妊娠研究 (PRESTO) 是北美一项基于网络的孕前队列研究。 在孕前阶段招募了超过 16,000 名女性和近 4,000 名男性伴侣，其中 20% 被认定为黑人、原住民或有色人种 (BIPOC) 的 PRESTO 参与者在此续签申请中， 我们建议再招募 8,000 名女性，以增强对睡眠进行更详细分析的能力 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 我们还建议收集和分析更多信息。 使用睡眠活动记录仪 (Fitbit Inspire 2) 和压力生物标记物（头发皮质醇和唾液酸）获得客观暴露数据 α-淀粉酶）在新参与者的子集中，我们将另外招募 2,000 名男性伴侣来增强。 检查男性暴露和双方的联合效应的能力，以确保关键假设的能力。 （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。 该应用程序建立在我们之前的工作基础上，表明压力和睡眠质量是睡眠质量的重要决定因素 我们更加关注未被充分研究的压力源——在代表性不足的人群中。 在生殖和围产期研究（例如男性和 BIPOC）中的应用——是新颖的且具有高度的公共卫生重要性。 孕前登记可最大限度地减少错误分类、选择偏差和反向因果关系，并尽早捕获 SAB（妊娠<8 周）是 NICHD 的一个优先领域，该队列的前瞻性设计、具有成本效益的网络- 用于参与者招募和跟进、地理和种族/民族异质性的基础设施，以及 全面收集双方合作伙伴的混杂数据是额外的优势 结果将生成数据。 可以为公共卫生干预措施提供信息，以减轻生育力低下和 SAB 的人口负担。