母亲接种百日咳疫苗对妊娠和分娩结局的安全性：一项前瞻性队列研究。
Safety of maternal pertussis vaccination on pregnancy and birth outcomes: A prospective cohort study.
机构信息
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia; Robinson Research Institute, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia.
Robinson Research Institute, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia; Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, Australia.
出版信息
Vaccine. 2021 Jan 8;39(2):324-331. doi: 10.1016/j.vaccine.2020.11.052. Epub 2020 Dec 19.
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 chorioamnionitis (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.
目的
评估母体百日咳疫苗接种对妊娠和分娩结局的安全性。
方法
本研究人群包括 2015 年至 2018 年在南澳大利亚的两家产科医院参加 Screening Tests to identify poor Outcomes in Pregnancy（STOP）研究的 1272 名健康初产妇。研究人员对参与者进行前瞻性随访，由研究助产士收集广泛的妊娠和分娩结局数据，并通过医疗记录确认疫苗接种情况。通过考虑疫苗暴露的时变特性和每个结局的时间性质，估计了调整后的相对风险（aRR）和调整后的危险比（aHR）。
结果
在这项研究中，纳入的 1272 名女性中，80.1%（n=1019）接受了母体百日咳疫苗接种。与未接种疫苗的女性相比，接种疫苗的女性分娩时的平均妊娠延长了 0.22 周（95%CI0.001，0.44）。母体百日咳疫苗接种与绒毛膜羊膜炎（aRR0.71，95%CI0.27，1.82）、妊娠期高血压（aHR1.24，95%CI0.66，2.30）、子痫前期（aHR0.75，95%CI0.47，1.18）或早产（aHR0.99，95%CI0.47，2.07）均无关。接种疫苗后，低出生体重（aHR0.72，95%CI0.41，1.27）或小于胎龄儿（aHR0.67，95%CI0.29，1.55）的风险均未增加。在妊娠期间接种百日咳疫苗与新生儿重症监护病房收治、低 Apgar 评分和机械通气等不良分娩结局之间也没有观察到关联。在调整了母体流感疫苗接种后，结果没有明显变化。
结论
本研究提供了令人安心的证据，表明母体百日咳疫苗接种是安全的，不会增加不良妊娠和分娩结局的风险。这些发现支持在妊娠期间接种百日咳疫苗以预防与婴儿早期百日咳疾病相关的发病率和死亡率的建议。
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