Safety of maternal pertussis vaccination on pregnancy and birth outcomes: A prospective cohort study
Safety of maternal pertussis vaccination on pregnancy and birth outcomes: A prospective cohort study
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DOI：
10.1016/j.vaccine.2020.11.052
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发表时间：
2021-01-08
期刊：
影响因子：
5.5
通讯作者：
Marshall, Helen S.
中科院分区：
文献类型：
--
作者：
Mohammed, Hassen;Roberts, Claire T.;Marshall, Helen S.
目的：评价孕妇接种百日咳疫苗对妊娠和出生结局的安全性。方法：研究人群包括1272名健康的未经产孕妇，他们参加了2015年至2018年在南澳两家产科医院进行的筛查试验，以确定妊娠不良结局（STOP）研究。参与者进行了前瞻性随访，接种疫苗（经医疗记录证实），研究助产士收集了大量的妊娠和出生结果数据。调整后的相对风险（aRRs）和风险比（aHRs）估计占随时间变化的疫苗暴露和时间性质的每个outcome.Results：在本研究中包括的1272名妇女，80.1%（n = 1019）接受孕产妇百日咳疫苗接种。与未接种疫苗的女性相比，接种疫苗的女性在分娩时的妊娠期平均延长0.22周（95%CI 0.001，0.44）。母亲接种百日咳疫苗与绒毛膜羊膜炎（aRR 0.71，95% CI 0.27，1.82）、妊娠期高血压（aHR 1.24，95% CI，0.66，2.30）、先兆子痫（aHR 0.75，95% CI 0.47，1.18）和早产（aHR 0.99，95% CI 0.47，2.07）无关。母亲接种百日咳疫苗后，低出生体重儿（aHR 0.72，95% CI 0.41，1.27）和小于胎龄儿（aHR 0.67，95% CI 0.29，1.55）的风险均未增加。未观察到妊娠期间接种百日咳疫苗与不良出生结局（包括新生儿监护室入院、低Apgar评分和机械通气）之间存在关联。结果没有实质性的变化后调整产妇流感vaccination.Conclusion：我们的研究提供了可靠的证据，产妇百日咳疫苗接种的安全性，没有增加不良妊娠和分娩结局的风险。这些发现支持妊娠期间接种百日咳疫苗的建议，以预防与早期婴儿百日咳疾病相关的发病率和死亡率。(C)2020爱思唯尔有限公司保留所有权利。
Objective: To evaluate the safety of maternal pertussis vaccination on pregnancy and birth outcomes.Methods: The study population comprised 1272 healthy nulliparous pregnant women who participated in Screening Tests to identify poor Outcomes in Pregnancy (STOP) study at two obstetric hospitals in South Australia between 2015 and 2018. Participants were followed prospectively, with vaccination (confirmed by medical records), extensive amounts of pregnancy and birth outcome data collected by research midwives. Adjusted relative risks (aRRs) and hazard ratios (aHRs) were estimated accounting for time-varying vaccine exposure and the temporal nature of each outcome.Results: Of the 1272 women included in this study, 80.1% (n = 1019) received maternal pertussis vaccination. Vaccinated women had an average 0.22 weeks (95% CI 0.001, 0.44) longer gestation at delivery compared to unvaccinated women. Maternal pertussis vaccination was not associated with chorioam-nionitis (aRR 0.71, 95% CI 0.27,1.82), gestational hypertension (aHR 1.24, 95% CI, 0.66, 2.30), preeclampsia (aHR 0.75, 95% CI 0.47, 1.18) nor preterm birth (aHR 0.99, 95% CI 0.47, 2.07). Neither risk of low birth weight (aHR 0.72, 95% CI 0.41, 1.27) nor small for gestational age infants (aHR 0.67,95% CI 0.29, 1.55) were increased following maternal pertussis vaccination. No associations between pertussis vaccination during pregnancy and adverse birth outcomes including admission to the neonatal care unit, low Apgar scores, and mechanical ventilation were observed. Results were not materially changed after adjustment for maternal influenza vaccination.Conclusion: Our study provides reassuring evidence of the safety of maternal pertussis vaccination with no increased risk of adverse pregnancy and birth outcomes. These findings support recommendations for pertussis vaccination during pregnancy to prevent morbidity and mortality associated with early-infant pertussis disease. (C) 2020 Elsevier Ltd. All rights reserved.