A Prospective Cohort Study to Examine Periconceptional Influenza Vaccination

一项检查围孕期流感疫苗接种情况的前瞻性队列研究

• 批准号: 10294869
• 负责人: Annette Karena Regan
• 金额: $ 7.61万
• 依托单位: UNIVERSITY OF SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10294869
• 关键词: Address; American; American College of Obstetricians and Gynecologists; Area; Centers for Disease Control and Prevention (U.S.); Cessation of life; Child; Clinical Research; Cohort Studies; Conceptions; Conflict (Psychology); Country; Data; Data Analyses; Decision Making; Enrollment; Evaluation; Exposure to; Family; Female; First Pregnancy Trimester; Health; Health Benefit; Health Personnel; Hospitalization; Immunization; Impairment; Infant; Influenza; Influenza vaccination; Knowledge; Lead; Left; Maternal Exposure; Meta-Analysis; Methodology; Morbidity - disease rate; Mothers; National Institute of Child Health and Human Development; Outcome; Parents; Participant; Paternal Exposure; Physicians; Planned Pregnancy; Pregnancy; Pregnancy Outcome; Pregnant Women; Prenatal care; Prospective Studies; Prospective cohort; Prospective cohort study; Provider; Randomized Controlled Trials; Recommendation; Reporting; Research; Risk; Safety; Sampling; Seasons; Spontaneous abortion; Time; United States; Vaccinated; Vaccination; Vaccines; Woman; World Health Organization; aged; base; cohort; early pregnancy; high risk; influenza virus vaccine; male; mortality; population based; pregnant; prenatal; prospective; recruit; vaccine trial

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.

项目摘要 孕妇因流感住院的可能性是非孕妇的五倍， 幼儿死于流感的可能性是年长儿童的四倍多。为了保护孕妇 美国妇产科医师学会建议， 在流感季节怀孕或将会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。尽管有这些 根据产前疫苗接种的建议和已证实的健康益处， 在怀孕期间接种疫苗，怀孕早期的接种率特别低。关切 疫苗接种对妊娠相关结局的安全性通常被认为是导致这一结果的因素。 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）风险， 妊娠结局可能是计划妊娠或妊娠早期女性特别关注的问题 他们的怀孕。迄今为止，所进行的研究都存在重大的方法缺陷。 此外，还没有研究评估父亲接触流感疫苗或健康的影响。 怀孕前接种疫苗的效果。这方面的有限证据可能会给父母及其子女带来挑战。 在疫苗接种决策过程中，疫苗提供者的行为，从而降低了公众对疫苗接种的信心。 受孕时间。医生报告的置信度较低证明了这一点， 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局限性是，招募在怀孕期间开始，这意味着， 处于妊娠早期阶段的妇女，SAB风险最高，接种疫苗的可能性较小 不包括在这些研究中。本研究旨在分析一组女性及其伴侣的数据 在怀孕前招募，以评估自然流产风险与 在怀孕前后的几周内接种流感疫苗。这项研究将考虑产妇和 父亲接种疫苗以及上一年接种疫苗的数量。为了解决这个问题， 一个研究小组计划分析11,150名女性和2,540名男性参与者的数据 在线（PRESTO）队列，一项北美前瞻性孕前队列研究。 流感疫苗接种目前被认为是保护孕妇及其 婴儿预防流感。使用来自大量女性及其男性伴侣的数据，该应用程序将 解决美国和其他国家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提出疫苗建议时， 在怀孕期间是否接种流感疫苗。