An internet-based preconception cohort study in North America and Denmark

摘要 拟议的补充剂回应了“COVID19疫苗接种和月经”(NOT-HD-21-035)。临床 试验没有评估SARS-CoV-2疫苗对月经和月经轶事报道的影响 SARS-CoV-2疫苗接种后的变化在社交媒体上广泛传播，引发了人们对疫苗的担忧 公众的安全。在线妊娠研究(Presto)是一项由NIH资助的前瞻性队列研究， 招募尝试受孕的女性，并在分娩后6个月内跟随她们从先入为主的状态 (R01HD086742)。符合条件的女性参与者年龄在21-45岁之间，是北美居民，试图 怀孕，而不是使用避孕或生育治疗。在2013年6月6日至2021年6月6日，Presto招收了更多 超过15,500名女性参与者。所有调查问卷均在线完成，数据收集工作将在 新冠肺炎大流行。在2020年4月，我们增加了关于新冠肺炎感染和相关压力源的新问题 大流行，包括生活方式、行为和医疗保健的改变，以及2021年1月，我们补充说 关于接种SARS-CoV-2疫苗的问题(接种过疫苗、疫苗类型和每次接种日期)。自.以来 研究开始时，女性已经报告了她们典型月经特征的基线数据，而不是 使用荷尔蒙。注册后，女性可以成为月经网站Kindara.com的高级会员 图表应用程序，在其中他们实时报告特定日期的月经数据。关于每双月一次的问卷 (管理长达12个月)，妇女报告关于她们最近的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个周期的随访期间月经变化有关。具体来说，我们将评估 SARS-CoV-2疫苗接种与周期不规则、周期长度、出血强度、持续时间的关系 出血、月经期斑点/出血，以及与月经有关的疼痛。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， 包括新冠肺炎相关的压力源。在1,800名完成≥1后续调查问卷的美国参与者中 2020年12月14日之后，我们将比较接种疫苗和未接种疫苗组的月经特征；我们 还将在800名接种疫苗的妇女中进行自我匹配分析(接种前和接种后)。在子集中 在使用金达拉报告特定日期月经数据的≥400名女性中，我们将描述与疫苗相关的特征 月经变化。我们的跨学科研究团队已经发表了大量与疫苗相关的文章 对健康的影响和月经特征，其中许多是基于Presto的数据，我们有 研究这些研究问题所需的专业知识。鉴于我们在整个过程中持续进行的前瞻性数据收集 大流行，我们成功招募了大量不使用激素的多样化女性，以及我们的 预期的月经数据收集，Presto的独特定位是分析疫苗接种和 并向科学界和公众提供有关疫苗安全性的基本信息。

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.