Covid‐19 Vaccination and Menstrual Health

Covid-19 疫苗接种和月经健康

• 批准号: 10433013
• 负责人: STACEY ANN MISSMER
• 金额: $ 20万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10433013
• 关键词: Accounting; Administrative Supplement; Affect; Age; Anxiety; COVID-19; COVID-19 pandemic; COVID-19 vaccination; Characteristics; Data; Data Collection; Disease; Distress; Economics; Female; Funding; Gynecologic; Hand; Health; Health Personnel; Home; Individual; Infection; Infertility; Infrastructure; Irregular Menstruation; Medical; Menorrhagia; Menstrual cycle; Menstruation; Mental Depression; Mental Health; Modification; Nurses' Health Study; Outcome; Parents; Participant; Pelvic Pain; Pelvis; Persons; Pharmaceutical Preparations; Population; Prospective cohort; Questionnaires; Reporting; Research; Resources; SARS-CoV-2 infection; Sample Size; Sampling; Series; Severities; Social isolation; Stress; Surveys; Symptoms; Time; Vaccinated; Vaccination; chronic pelvic pain; cohort; coping mechanism; cost; endometriosis; frailty; health care availability; human data; interest; pandemic disease; psychosocial; sample collection; social

PROJECT SUMMARY/ABSTRACT Despite prevalent anecdotal reports, the impact of SARS-CoV-2 infection or vaccination on menorrhagia and menstrual regularity has not been investigated. COVID-19 disease has impacted millions, while stay-at-home orders and heightened stress have impacted billions. Menorrhagia, menstrual irregularity, and chronic pelvic pain (with or without endometriosis) are known to increase in severity when challenged with stress, unraveling of personal coping mechanisms, or diminished access to healthcare – all of which occurred during the COVID- 19 pandemic. To successfully assess changes in menstrual and gynecologic characteristics attributable to SARS-CoV-2 infection or vaccination, it is critical to compare post-infection or post-vaccination menstruation and pelvic symptoms to that person’s pre-exposure menstruation and also to compare menstruation among those who have been infected or vaccinated to those who have not, accounting for pandemic impacts that may vary by individual social or economic frailty and mental health. Answering these critical questions with scientific rigor in existing research cohort populations is responsive to Notice of Special Interest (NOSI) to Encourage Administrative Supplement Applications to Investigate COVID-19 Vaccination and Menstruation (NOT-HD-21- 035). Our Parent R01 funding focuses on infertility and long-term health outcomes within the Harvard Cohorts, primarily within the Nurses’ Health Study II. While the current age range of NHSII cohort does not accommodate menstrual-change focused discovery, our team and infrastructure also include leaders and resources from the Nurses’ Health Study 3 (NHS3; age 19-51 years at baseline) that began in 2010 and the Growing Up Today Study (GUTS) that began in 1996 (current age 24-39 years). A year-long series of COVID-19 pandemic surveys were launched in April 2020. Baseline COVID-19 surveys were completed by 40% (N=11,976) of female NHS3 participants among whom 80% of responders are frontline healthcare providers and 41% (N=4,681) of female GUTS participants among whom 22% of responders are frontline healthcare providers. Within these two harmonized cohorts, we will confirm if 1) SARS-CoV-2 infection or 2) vaccination are associated with incident or worsened menorrhagia, menstrual irregularity or pelvic pain compared to pre-pandemic, pre-infection, or pre- vaccination menstrual characteristics and compared to those who have neither been infected nor vaccinated; and 3) increase in COVID-19 pandemic-related distress (e.g. depression, anxiety, social isolation, economic peril) will be associated with incident or increased severity of menorrhagia, menstrual cycle irregularity, or chronic pelvic pain – independent of SARS-CoV-2 infection or vaccination. While many are scrambling to assemble research teams and establish de novo human data and sample collection, which will yield uncertain deliverables, small samples sizes, and often reliance on fully de-identified samples from which confounding and modification cannot be validly assessed, the proposed study capitalizes on well-established resources providing cost and time efficiency as well as scientifically robust opportunity.

项目总结/摘要 尽管有流行的轶事报道，但SARS-CoV-2感染或疫苗接种对月经过多和 月经规律尚未研究。COVID-19疾病影响了数百万人，而留在家里 订单和压力的增加影响了数十亿人。月经过多、月经不调和慢性盆腔炎 疼痛（有或没有子宫内膜异位症）是已知的，以增加严重程度时，挑战与压力，解开 个人应对机制，或减少获得医疗保健-所有这些都发生在新冠肺炎期间- 19大流行病。为了成功评估归因于以下因素的月经和妇科特征的变化： SARS-CoV-2感染或疫苗接种后，比较感染后或疫苗接种后的月经和 骨盆症状与该人暴露前的月经，并比较这些人的月经 已经感染或接种疫苗的人与没有感染或接种疫苗的人相比， 由个人社会或经济弱点和心理健康。用科学的严谨性来回答这些关键问题 在现有的研究队列人群中， 调查COVID-19疫苗接种和月经的行政补充申请（NOT-HD-21- 035）。我们的父母R 01基金专注于哈佛队列中的不孕症和长期健康结果， 主要是在护士健康研究II中。虽然NHSII队列的当前年龄范围不适应 我们的团队和基础架构还包括来自 2010年开始的护士健康研究3（NHS 3;基线年龄为19-51岁）和今天的成长 研究（GUTS）开始于1996年（当前年龄24-39岁）。为期一年的2019冠状病毒病疫情调查系列 于二零二零年四月推出。40%（N= 11，976）的女性NHS完成了基线COVID-19调查3 参与者中，80%的应答者是一线医疗保健提供者，41%（N= 4，681）的女性 GUTS参与者中，22%的响应者是一线医疗保健提供者。在这两 协调队列，我们将确认1）SARS-CoV-2感染或2）疫苗接种是否与事件或 与大流行前、感染前或 接种疫苗的月经特征，并与那些既没有感染也没有接种疫苗的人进行比较; 以及3）与COVID-19大流行相关的痛苦（例如抑郁、焦虑、社会孤立、经济 危险）将与月经过多、月经周期不规则或慢性月经失调的发生或严重程度增加相关。 盆腔疼痛-与SARS-CoV-2感染或疫苗接种无关。虽然许多人争先恐后地组装 研究团队和建立重新的人类数据和样本收集，这将产生不确定的交付成果， 样本量小，并且通常依赖于完全去识别的样本， 不能有效地评估，拟议的研究利用了完善的资源提供成本和 时间效率以及科学上的强大机会。