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

项目摘要/摘要 尽管坊间报道盛行，但SARS-CoV-2感染或接种疫苗对月经过多和 月经规律在很大程度上仍然没有记录，也没有研究。新冠肺炎病已经影响了数百万人， 而居家订单和不断增加的压力已经影响了数十亿美元。月经过多，月经不规律， 慢性盆腔疼痛(有或不伴有子宫内膜异位症)在挑战时会加重 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 在新冠肺炎大流行期间。成功评估月经和妇科特征的变化 可归因于SARS-CoV-2感染或接种，关键是比较感染后或接种后 月经和盆腔症状与接触前月经情况也进行比较 已感染或未接种疫苗的人的月经情况，占 大流行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。回答这些问题 现有研究队列人群中具有科学严谨性的关键问题对特殊通知的响应 有兴趣(NOSI)鼓励行政补充申请调查新冠肺炎疫苗接种和 月经(非HD-21-035)。我们将利用一项正在进行的前瞻性研究，即妇女健康研究： 青春期到成年期(A2A，N=1569)--包括在父母R01(HD094842)中的核心队列。队列 参与者自2012年开始注册以来，已经完成了年度问卷调查，其中包括评估 月经特征。利用这一队列来比较和对比预期收集的 和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 感染与发生或加重月经过多、月经不规律或盆腔疼痛有关，与 大流行前和感染前女性的月经特征，并与 没有被感染；b)接种SARS-CoV-2疫苗与发生或加重月经过多有关， 月经不规律或盆腔疼痛，如坊间报道的那样，与接种疫苗前的月经相比 个人特征，并与未接种疫苗的妇女相比；以及c)新冠肺炎的增加 与流行病有关的痛苦(如抑郁、焦虑、社会孤立、经济危险)和减少的健康 应对将与月经过多、月经周期不规律或月经周期异常的事件或严重程度有关 慢性盆腔疼痛--与SARS-CoV-2感染或疫苗接种无关。当许多人争先恐后地 召集研究团队，建立新的人类数据和样本收集，这将产生不确定的结果 可交付成果小，样本量小，通常依赖完全未识别的样本，从这些样本中产生混淆和 无法有效地评估修改，拟议的研究利用了成熟的资源，提供了 成本和时间效率以及科学上强大的机会。

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.