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围产期结局与孕期接种国药集团北京生物制品研究所的新型冠状病毒灭活疫苗(BBIBP-CorV)

Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy.

作者信息

Hatami Donya, Habibelahi Abbas, Changizi Nasrin, Heidarzadeh Mohammad, Nojomi Marzieh, Rast Moein, Ansari Kiarash, Tehrani-Banihashemi Arash

机构信息

Preventive Medicine and Public Health Research Center, Psychosocial Health Research Institute, Department of Community and Family Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

Neonatal Health Office, Ministry of Health and Medical Education, Tehran, Iran.

出版信息

BMC Pregnancy Childbirth. 2024 Mar 11;24(1):190. doi: 10.1186/s12884-024-06389-z.

Abstract

BACKGROUND

After the outbreak of COVID-19, a huge part of the health care services was dedicated to preventing and treating this disease. In case of COVID-19 infection, severe COVID-19 is reported more in pregnant individuals. Afterward, Vaccination against SARS-CoV-2 became a hot topic due to known effects in preventing severe COVID-19 during pregnancy. Vaccination of pregnant individuals started in August 2021 with the Sinopharm vaccine in Iran. The aim of current study was to determine the incidence of perinatal outcomes in women who were vaccinated during pregnancy.

METHOD

This retrospective cohort study included 129,488 singleton births from March 21, 2021, until March 21, 2022, in Tehran, Iran. The data was obtained from the Iranian Maternal and Neonatal (IMaN) Network and the Maternal Vaccination Registry. Adverse perinatal outcomes investigated in this study include preterm birth, extremely preterm birth, low birth weight, very low birth weight, intrauterine growth restriction, stillbirth, neonatal intensive care unit admission, congenital anomaly, neonatal death and low 5-minute Apgar score. The risk of all perinatal outcomes was evaluated using multiple logistic regression. The analysis was done using STATA version 14.

RESULTS

Of all 129,488 singleton births included in this study, 17,485 (13.5%) were vaccinated against SARS-CoV-2 (all with Sinopharm (BBIBP-CorV)). The exposure to the Sinopharm vaccine during pregnancy caused a significant decrease in the incidence of preterm birth (P =0.006, OR=0.91 [95% CI, 0.85 to 0.97]), extremely preterm birth (P =<0.001,OR=0.55 [95% CI, 0.45 to 0.66]), and stillbirth (P =<0.001, OR=0.60 [95% CI, 0.47 to 0.76]). Exposure to vaccination during the first trimester was associated with an increased risk of preterm birth (P =0.01, OR=1.27 [95% CI, 1.04 to 1.55]) Maternal vaccination during pregnancy was not associated with an increased risk of other adverse perinatal outcomes included in this study.

CONCLUSION

The finding of this population-based study indicated no adverse pregnancy outcome due to vaccination with the Sinopharm vaccine during the second and third trimesters of pregnancy. Overall risk of adverse pregnancy outcomes were lower in the vaccinated individuals compared to the unvaccinated group. Also, vaccination during the first trimester was associated with an increased risk of preterm birth.

摘要

背景

新型冠状病毒肺炎(COVID-19)疫情爆发后,医疗服务的很大一部分致力于预防和治疗这种疾病。在COVID-19感染病例中,孕妇患重症COVID-19的报道更多。此后,由于已知SARS-CoV-2疫苗在预防孕期重症COVID-19方面的作用,针对SARS-CoV-2的疫苗接种成为一个热门话题。伊朗于2021年8月开始为孕妇接种国药集团疫苗。本研究的目的是确定孕期接种疫苗的女性围产期结局的发生率。

方法

这项回顾性队列研究纳入了2021年3月21日至2022年3月21日在伊朗德黑兰的129488例单胎分娩。数据来自伊朗母婴(IMaN)网络和孕产妇疫苗接种登记处。本研究调查的不良围产期结局包括早产、极早产、低出生体重、极低出生体重、胎儿生长受限、死产、新生儿重症监护病房入院、先天性异常、新生儿死亡和5分钟阿氏评分低。使用多因素逻辑回归评估所有围产期结局的风险。分析使用STATA 14版完成。

结果

在本研究纳入的所有129488例单胎分娩中,17485例(13.5%)接种了SARS-CoV-2疫苗(均为国药集团(BBIBP-CorV)疫苗)。孕期接种国药集团疫苗导致早产发生率显著降低(P =0.006,OR=0.91[95%CI,0.85至0.97])、极早产发生率显著降低(P =<0.001,OR=0.55[95%CI,0.45至0.66])和死产发生率显著降低(P =<0.001,OR=0.60[95%CI,0.47至0.76])。孕早期接种疫苗与早产风险增加相关(P =0.01,OR=1.27[95%CI,1.04至1.55])。孕期母亲接种疫苗与本研究中纳入的其他不良围产期结局风险增加无关。

结论

这项基于人群的研究结果表明,孕期第二和第三阶段接种国药集团疫苗不会导致不良妊娠结局。与未接种疫苗的组相比,接种疫苗的个体不良妊娠结局的总体风险较低。此外,孕早期接种疫苗与早产风险增加相关。

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