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: 10434313
• 负责人: ELIZABETH E HATCH
• 金额: $ 29.93万
• 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/10434313
• 关键词: Address; Administrative Supplement; Age; Behavior; COVID-19; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Canada; Characteristics; Clinical Trials; Cohort Studies; Collection; Communities; Contraceptive methods; Data; Data Collection; Denmark; Dysmenorrhea; Enrollment; Female; Funding; Geography; Goals; Health; Healthcare; Hemorrhage; Immune response; Inflammatory; Infrastructure; Interdisciplinary Study; Internet; Investigation; Length; Life Style; Long-Term Effects; Measures; Menstrual cycle; Menstruation; North America; Online Systems; Pain; Participant; Pattern; Population Heterogeneity; Positioning Attribute; Pregnancy; Process; Prospective cohort study; Publishing; Questionnaires; Reporting; Research; SARS-CoV-2 infection; Spottings; Text; Time; Time trend; United States; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Woman; adverse pregnancy outcome; aged; base; cohort; follow-up; infertility treatment; pandemic disease; prospective; receptor; recruit; reproductive; research study; secondary analysis; social media; socioeconomics; stressor; subfertility; trying to conceive; vaccine safety

ABSTRACT The proposed supplement responds to “COVID19 Vaccination and Menstruation” (NOT-HD-21-035). Clinical trials did not evaluate the influence SARS-CoV-2 vaccine on menstruation and anecdotal reports of menstrual changes after SARS-CoV-2 vaccination have circulated widely on social media, raising concerns about vaccine safety among the public. Pregnancy Study Online (PRESTO) is an NIH-funded prospective cohort study that enrolls women trying to conceive and follows them from preconception through 6 months after delivery (R01HD086742). Eligible female participants are aged 21-45 years, residents of North America, trying to conceive, and not using contraception or fertility treatment. During 6/2013-6/2021, PRESTO has enrolled more than 15,500 female participants. All questionnaires are completed online and data collection continued during the COVID-19 pandemic. In April 2020, we added new questions on COVID-19 infection and stressors related to the pandemic, including changes in lifestyle, behaviors and health care, and in January 2021, we added questions on SARS-CoV-2 vaccination (ever vaccinated, type of vaccine, and date of each shot). Since the study's inception, women have reported baseline data about their typical menstrual characteristics while not using hormones. After enrollment, women are offered a premium membership to Kindara.com, a menstrual charting app, in which they report day-specific menstrual data in real-time. On each bimonthly questionnaire (administered for up to 12 months), women report additional data about their most recent menstrual cycles. We will use the above prospectively-collected data to examine the extent to which SARS-CoV-2 vaccination is associated with changes in menstruation during 6 cycles of follow-up. Specifically, we will evaluate the association between SARS-CoV-2 vaccination and cycle irregularity, cycle length, intensity of bleed, duration of bleed, intermenstrual spotting/bleeding, and pain associated with menses. We will consider various windows of possible effects and identify the duration of any observed changes. We will control for several confounders, including COVID-19-related stressors. Among 1,800 U.S. participants who completed ≥1 follow-up questionnaire after 12/14/2020, we will compare menstrual characteristics between vaccinated and unvaccinated groups; we will also perform a self-matched analysis among 800 vaccinated women (pre- vs. post-vaccination). In the subset of ≥400 women who reported day-specific menstrual data using Kindara, we will characterize vaccine-related changes in menstruation. Our interdisciplinary research team has published extensively on vaccine-related health effects and menstrual characteristics, many of which are based on PRESTO data, and we have the expertise necessary to study these research questions. Given our ongoing prospective data collection throughout the pandemic, our successful recruitment of a large, diverse population of women not using hormones, and our prospective collection of menstrual data, PRESTO is uniquely-positioned to analyze data on vaccination and menstruation and provide essential information to the scientific community and the public on vaccine safety.

摘要 拟议的补充材料对“COVID 19疫苗接种和月经”（NOT-HD-21-035）做出了回应。临床 试验没有评估SARS-CoV-2疫苗对月经的影响， SARS-CoV-2疫苗接种后的变化在社交媒体上广泛传播，引起了人们对疫苗的担忧。 公众的安全。Pregnancy Study Online（PRESTO）是一项由NIH资助的前瞻性队列研究， 招募试图怀孕的妇女，并对她们从怀孕前到分娩后6个月进行随访。 （R01HD086742）。符合条件的女性参与者年龄在21-45岁之间，居住在北美， 怀孕，不使用避孕或生育治疗。在2013年6月至2021年6月期间，PRESTO招募了更多 超过15，500名女性参与者。所有调查问卷都在网上完成，数据收集工作在2010年期间继续进行。 COVID-19大流行。2020年4月，我们增加了关于COVID-19感染和压力因素的新问题 包括生活方式，行为和医疗保健的变化，并在2021年1月，我们补充说， 关于SARS-CoV-2疫苗接种的问题（是否接种过疫苗，疫苗类型和每次接种的日期）。以来 研究开始时，妇女报告了关于她们典型月经特征的基线数据， 使用荷尔蒙。注册后，女性可以获得Kindara.com的高级会员资格， 图表应用程序，他们在其中实时报告特定日期的月经数据。在每两个月一次的调查问卷中， （给药长达12个月），妇女报告有关其最近月经周期的额外数据。我们 将使用上述前瞻性收集的数据来检查SARS-CoV-2疫苗接种的程度， 与6个周期随访期间的月经变化相关。具体来说，我们将评估 SARS-CoV-2疫苗接种与周期不规则性、周期长度、出血强度、 出血、经间期点滴/出血和与月经有关的疼痛。我们将考虑各种窗口， 可能的影响，并确定任何观察到的变化的持续时间。我们将控制几个混杂因素， 包括与COVID-19相关的压力因素。在完成≥1份随访问卷的1，800名美国参与者中 2020年12月14日之后，我们将比较接种疫苗组和未接种疫苗组之间的月经特征;我们 还将在800名接种疫苗的妇女中进行自我匹配分析（接种疫苗前与接种疫苗后）。子集中 在≥400名使用Kindara报告特定日期月经数据的女性中，我们将描述疫苗相关的 月经的变化。我们的跨学科研究团队在疫苗相关领域发表了大量文章， 健康影响和月经特征，其中许多是基于PRESTO数据，我们有 研究这些研究问题所需的专业知识。考虑到我们在整个过程中正在进行的前瞻性数据收集， 大流行病，我们成功招募了大量不使用激素的各种妇女， 前瞻性收集月经数据，PRESTO被定位为分析疫苗接种数据， 我们的工作是为妇女和青少年提供疫苗，并为科学界和公众提供有关疫苗安全性的基本信息。