Menstrual health during the Covid-19 pandemic: A longitudinal study among young people with and without endometriosis

Covid-19 大流行期间的月经健康：对患有和不患有子宫内膜异位症的年轻人进行的纵向研究

• 批准号: 10434356
• 负责人: Asgerally T. Fazleabas
• 金额: $ 27.46万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10434356
• 关键词: Accounting; Administrative Supplement; Adolescence; Adolescent and Young Adult; Adult; Affect; Anxiety; COVID-19; COVID-19 pandemic; COVID-19 vaccination; Characteristics; Data; Data Collection; Disease; Distress; Economics; Enrollment; Gynecologic; Hand; Health; Home; Individual; Infection; Irregular Menstruation; Longitudinal Studies; Medical; Menorrhagia; Menstrual cycle; Menstruation; Mental Depression; Mental Health; Modification; Parents; Participant; Pelvic Pain; Pelvis; Persons; Pharmaceutical Preparations; Population; Prospective Studies; Questionnaires; Reporting; Research; Resources; SARS-CoV-2 infection; Sample Size; Sampling; Series; Severities; Social isolation; Stress; Symptoms; Testing; Time; Vaccinated; Vaccination; Woman; Women' s Health; chronic pelvic pain; cohort; coping; coping mechanism; cost; endometriosis; frailty; health care availability; human data; inflammatory marker; interest; pandemic disease; prospective; 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 remains largely undocumented and unstudied. 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). We will utilize an ongoing prospective study, the Women’s Health Study: from Adolescence to Adulthood (A2A, N=1569) - the core cohort included in the Parent R01 (HD094842). Cohort participants have completed annual questionnaires since enrollment began in 2012, which includes assessment of menstrual characteristics. Leveraging this cohort to compare and contrast prospectively collected pre-, peri-, and post-pandemic characteristics and inflammatory markers, we will test these hypotheses: a) SARS-CoV-2 infection is associated with incident or worsened menorrhagia, menstrual irregularity or pelvic pain compared to pre-pandemic and pre-infection menstrual characteristics within individual women, and compared to women who have not been infected; b) SARS-CoV-2 vaccination is associated with incident or worsened menorrhagia, menstrual irregularity or pelvic pain, as has been reported anecdotally, compared to pre-vaccination menstrual characteristics within individuals, and compared to unvaccinated women; and c) Increase in COVID-19 pandemic-related distress (e.g. depression, anxiety, social isolation, economic peril) and diminished healthy coping 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.

项目概要/摘要 尽管有普遍的轶事报道，但 SARS-CoV-2 感染或疫苗接种对月经过多和 月经规律在很大程度上仍然没有记录和研究，COVID-19 疾病已经影响了数百万人， 居家令和肠胃压力影响了数十亿人的月经过多、月经不调、 已知慢性盆腔疼痛（伴或不伴子宫内膜异位症）在受到以下挑战时会加重 压力、个人应对机制瓦解或获得医疗保健的机会减少——所有这些都发生了 在 COVID-19 大流行期间成功评估月经和妇科特征的变化。 由于 SARS-CoV-2 感染或疫苗接种所致，因此比较感染后或疫苗接种后的情况至关重要 将月经和盆腔症状与该人暴露前的月经进行比较 已感染者的月经或未感染者的肺炎，占 流行病的影响可能因个人的社会或经济脆弱性和心理健康状况而异。 现有研究群体中科学研究的关键问题是对特别通知的回应 有兴趣 (NOSI) 鼓励行政补充申请以调查 COVID-19 疫苗接种和 我们将利用一项正在进行的前瞻性研究，即女性健康研究：来自 青春期到成年 (A2A, N=1569) - 包含在父队列 (HD094842) 中的核心队列。 自2012年开始招募以来，参与者已完成年度调查问卷，其中包括评估 利用该队列来比较和对比前瞻性收集的月经前、月经期、月经期特征。 以及大流行后的特征和炎症标志物，我们将检验这些假设：a) SARS-CoV-2 与女性相比，感染与月经过多、月经不规律或盆腔疼痛的发生或恶化有关 个别女性在大流行前和感染前的月经特征，并与以下女性进行比较 未感染；b) SARS-CoV-2 疫苗接种与月经过多事件或恶化有关， 据传闻，与接种疫苗前的月经相比，月经不规律或盆腔疼痛 个人特征以及与未接种疫苗的女性相比；c) COVID-19 的增加 与流行病相关的痛苦（例如抑郁、焦虑、社会孤立、经济危险）和健康状况恶化 应对措施与月经过多、月经周期不规则的发生或严重程度增加有关，或 慢性盆腔疼痛——与 SARS-CoV-2 感染或疫苗接种无关，而许多人都在争先恐后地采取这种方法。 组建研究团队并建立从头开始的人类数据和样本收集，这将产生不确定的结果 可交付成果、样本量小，并且通常依赖于完全去识别化的样本，其中混杂和 修改无法得到有效评估，拟议的研究利用了既定的资源，提供 成本和时间效率以及科学上可靠的机会。