A Prospective Cohort Study to Examine Periconceptional Influenza Vaccination

项目总结 孕妇患流感住院的可能性是非孕妇的五倍， 婴儿死于流感的可能性是较大儿童的四倍多。为了保护孕妇 妇女和她们的婴儿，美国妇产科医生学会建议所有 在流感季节怀孕或将要怀孕的妇女应接种流感疫苗。基于 根据目前的建议，流感疫苗接种目前是标准产前护理的一部分。尽管如此 产前接种疫苗的建议和证明的健康益处，不到40%的母亲 在怀孕期间接种疫苗，在怀孕早期的疫苗接种率特别低。令人担忧的问题 对于妊娠相关结果的疫苗接种的安全性，通常被认为是导致这种情况的因素 免疫接种率低。 很少有研究评估与流感疫苗接种相关的自然流产(SAB)的风险。 怀孕结局可能是计划怀孕或怀孕前三个月妇女特别关注的问题 关于她们怀孕的事。到目前为止，已经进行的研究在方法上存在重大缺陷。 此外，还没有研究评估父亲接触流感疫苗对健康的影响。 怀孕前接种疫苗的效果。这一领域的有限证据可能会给父母和他们的父母带来挑战 在疫苗接种问题上做出决策，从而降低了公众对疫苗接种的信心 怀孕的时间。医生报告的信心较低的情况证明了这一点 建议怀孕前三个月的妇女接种疫苗。 现有疫苗研究的一个共同限制是招募始于怀孕期间，这意味着 怀孕初期感染SAB风险最高且不太可能接种疫苗的妇女 不包括在这些研究中。这项研究旨在分析一组女性及其伴侣的数据 在受孕前招募，以评估自然流产风险和 在怀孕前后的几周内接种流感疫苗。这项研究将同时考虑产妇和 父亲接种疫苗的数量以及前一年接种疫苗的数量。为了解决这个问题， 研究小组计划分析11150名女性和2540名男性参与怀孕研究的数据 在线(Presto)队列，一项北美前瞻性先入为主的队列研究。 流感疫苗接种目前被认为是保护孕妇和她们的 婴儿预防流感。使用来自一大群女性及其男性伴侣的数据，这款应用程序将 解决美国和其他国家的产前护理的一个重要问题。研究结果将有助于 临床医生在评估是否推荐疫苗时以及家庭在他们的决策中 关于是否在怀孕前后接种流感疫苗。

PROJECT SUMMARY Pregnant women are up to five times more likely to be hospitalized with influenza than non-pregnant women, and young infants are more than four times as likely as older children to die from influenza. To protect pregnant women and their infants, the American College of Obstetricians and Gynecologists recommends that all women who are or will be pregnant during influenza season should receive an influenza vaccine. Based on current recommendations, influenza vaccination is currently part of standard prenatal care. Despite these recommendations and the demonstrated health benefits of prenatal vaccination, fewer than 40% of mothers are vaccinated during pregnancy, and vaccination rates are especially low during early pregnancy. Concerns for the safety of vaccination on pregnancy-related outcomes are commonly cited as contributing factors to this low rate of immunization. Few studies have evaluated the risk of spontaneous abortion (SAB) associated with influenza vaccination, a pregnancy outcome which may be a particular concern for women planning pregnancy or in the first trimester of their pregnancy. To date, what studies have been conducted have had major methodological flaws. Furthermore, no study has yet evaluated the impacts of paternal exposure to influenza vaccines or the health effects of pre-conception vaccination. Limited evidence in this area can present challenges to parents and their providers while making decisions on vaccination, thereby reducing public confidence in vaccination around the time of conception. This has been demonstrated by the lower confidence reported by physicians when recommending vaccination for women in their first trimester. A common limitation to existing vaccine studies is that recruitment begins during pregnancy, meaning that women in the earliest stages of pregnancy who are at highest risk of SAB and are less likely to be vaccinated are not included in these studies. This study aims to analyze data from a cohort of women and their partners recruited prior to conception in order to evaluate the association between the risk of spontaneous abortion and influenza vaccination during the weeks prior to and after conception. This study will consider both maternal and paternal vaccination as well as the number of vaccinations received in the previous year. To address this, the research team plans to analyze data from 11,150 female and 2,540 male participants of the Pregnancy Study Online (PRESTO) cohort, a North American prospective preconception cohort study. Influenza vaccination is currently considered the optimal strategy for protecting pregnant women and their infants against influenza. Using data from a large, cohort of women and their male partners, this application will address an important issue for prenatal care in the US and other countries. Study results will be useful to clinicians when evaluating whether to make vaccine recommendations and by families in their decision-making on whether to receive influenza vaccine around the time of conception.