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Abstract：
UNASSIGNED: Whether hepatitis B virus (HBV) infection of women prior to pregnancy can influence risk of congenital malformations in offspring remains controversial. We assessed the association between them by considering congenital malformations in the aggregate as well as risk of organs systems using a large national sample of Chinese women.
UNASSIGNED: We performed a record-linkage cohort study of women who participated in National Free Preconception Health Examination Project, between January 1, 2010, and December 31, 2019 for whom data on congenital malformations in their offspring were available from the National Population-Based Birth Defects Surveillance Network. A total of 498,968 linked records were obtained, of which 127,371 were excluded because HBV status before pregnancy was unknown, the records involved multiple pregnancies, or pre-pregnancy examinations were conducted after conception. Based on pre-pregnancy status, mothers were assigned to two categories of HBsAg- or HBsAg+ and, in certain analyses, to three categories of HBsAg-, HBsAg+/HBeAg- or HBsAg+/HBeAg+. Potential associations of serological status with risk of congenital malformations, considered separately or in aggregate, were explored using multilevel logistic regression. Factors that might influence such associations were also explored.
UNASSIGNED: Among the 371,597 women analyzed, 21,482 (5.78%) were HBsAg+ before pregnancy, and 8333 (2.24%) had a fetus or child diagnosed with congenital malformations, composed of 7744 HBsAg- women and 589 HBsAg+ women. HBsAg+ status was associated with increased risk of congenital malformations in the aggregate (OR 1.14, 95% CI 1.03-1.25) and of cardiovascular malformations specifically (OR 1.18, 95% CI 1.03-1.35). HBsAg+/HBeAg- status was associated with significantly higher risk of cardiovascular malformations (OR 1.19, 95% CI 1.01-1.39) as well as reproductive malformations (OR 1.51, 95% CI 1.02-2.23). Associations between HBsAg+ status before pregnancy and risk of congenital malformations was modified by alanine aminotransferase activity (P interaction < 0.05).
UNASSIGNED: Prepregnancy HBV infection might be associated with fetal malformations. This association needs further investigation to confirm whether it is a causal association, and assess whether antiviral therapy of women with HBsAg+ planning to conceive might reduce the risk of fetal malformations.
UNASSIGNED: The National Health Commission of the People\'s Republic of China, China; Science and Technology Department of Sichuan Province, China; and the Ministry of Science and Technology of the People\'s Republic of China.
UNASSIGNED: We performed a record-linkage cohort study of women who participated in National Free Preconception Health Examination Project, between January 1, 2010, and December 31, 2019 for whom data on congenital malformations in their offspring were available from the National Population-Based Birth Defects Surveillance Network. A total of 498,968 linked records were obtained, of which 127,371 were excluded because HBV status before pregnancy was unknown, the records involved multiple pregnancies, or pre-pregnancy examinations were conducted after conception. Based on pre-pregnancy status, mothers were assigned to two categories of HBsAg- or HBsAg+ and, in certain analyses, to three categories of HBsAg-, HBsAg+/HBeAg- or HBsAg+/HBeAg+. Potential associations of serological status with risk of congenital malformations, considered separately or in aggregate, were explored using multilevel logistic regression. Factors that might influence such associations were also explored.
UNASSIGNED: Among the 371,597 women analyzed, 21,482 (5.78%) were HBsAg+ before pregnancy, and 8333 (2.24%) had a fetus or child diagnosed with congenital malformations, composed of 7744 HBsAg- women and 589 HBsAg+ women. HBsAg+ status was associated with increased risk of congenital malformations in the aggregate (OR 1.14, 95% CI 1.03-1.25) and of cardiovascular malformations specifically (OR 1.18, 95% CI 1.03-1.35). HBsAg+/HBeAg- status was associated with significantly higher risk of cardiovascular malformations (OR 1.19, 95% CI 1.01-1.39) as well as reproductive malformations (OR 1.51, 95% CI 1.02-2.23). Associations between HBsAg+ status before pregnancy and risk of congenital malformations was modified by alanine aminotransferase activity (P interaction < 0.05).
UNASSIGNED: Prepregnancy HBV infection might be associated with fetal malformations. This association needs further investigation to confirm whether it is a causal association, and assess whether antiviral therapy of women with HBsAg+ planning to conceive might reduce the risk of fetal malformations.
UNASSIGNED: The National Health Commission of the People\'s Republic of China, China; Science and Technology Department of Sichuan Province, China; and the Ministry of Science and Technology of the People\'s Republic of China.
摘要：
■怀孕前妇女感染乙型肝炎病毒（HBV）是否会影响后代先天性畸形的风险仍存在争议。我们通过使用大量的中国女性全国样本，通过考虑总体上的先天性畸形以及器官系统的风险来评估它们之间的关联。
■我们对参加全国免费孕前健康检查项目的女性进行了一项记录联系队列研究，在2010年1月1日至2019年12月31日期间，可以从国家基于人口的出生缺陷监测网络获得有关其后代先天性畸形的数据。总共获得了498,968条链接记录，其中127,371被排除，因为怀孕前HBV状态未知，记录涉及多胎妊娠,或怀孕后进行孕前检查。根据孕前状况,母亲被分配到两个类别的HBsAg-或HBsAg+和，在某些分析中，到三类HBsAg-，HBsAg+/HBeAg-或HBsAg+/HBeAg+。血清学状态与先天性畸形风险的潜在关联，单独或总体考虑，使用多水平逻辑回归进行了探索。还探讨了可能影响此类关联的因素。
■在分析的371597名女性中，21,482（5.78％）怀孕前HBsAg+，和8333（2.24％）的胎儿或儿童被诊断为先天性畸形，由7744HBsAg-女性和589HBsAg+女性组成。HBsAg+状态与总体先天性畸形（OR1.14，95％CI1.03-1.25）和心血管畸形（OR1.18，95％CI1.03-1.35）的风险增加相关。HBsAg+/HBeAg-状态与心血管畸形（OR1.19，95％CI1.01-1.39）以及生殖畸形（OR1.51，95％CI1.02-2.23）的风险显着升高。妊娠前HBsAg+状态与先天性畸形风险之间的关联由丙氨酸转氨酶活性修饰（P交互作用<0.05）。
■孕前HBV感染可能与胎儿畸形有关。这种关联需要进一步调查，以确认它是否是因果关系，并评估HBsAg+计划怀孕的女性的抗病毒治疗是否可能降低胎儿畸形的风险。
■中华人民共和国国家卫生健康委员会,中国；四川省科学技术厅，中国；和中华人民共和国科学技术部。
■我们对参加全国免费孕前健康检查项目的女性进行了一项记录联系队列研究，在2010年1月1日至2019年12月31日期间，可以从国家基于人口的出生缺陷监测网络获得有关其后代先天性畸形的数据。总共获得了498,968条链接记录，其中127,371被排除，因为怀孕前HBV状态未知，记录涉及多胎妊娠,或怀孕后进行孕前检查。根据孕前状况,母亲被分配到两个类别的HBsAg-或HBsAg+和，在某些分析中，到三类HBsAg-，HBsAg+/HBeAg-或HBsAg+/HBeAg+。血清学状态与先天性畸形风险的潜在关联，单独或总体考虑，使用多水平逻辑回归进行了探索。还探讨了可能影响此类关联的因素。
■在分析的371597名女性中，21,482（5.78％）怀孕前HBsAg+，和8333（2.24％）的胎儿或儿童被诊断为先天性畸形，由7744HBsAg-女性和589HBsAg+女性组成。HBsAg+状态与总体先天性畸形（OR1.14，95％CI1.03-1.25）和心血管畸形（OR1.18，95％CI1.03-1.35）的风险增加相关。HBsAg+/HBeAg-状态与心血管畸形（OR1.19，95％CI1.01-1.39）以及生殖畸形（OR1.51，95％CI1.02-2.23）的风险显着升高。妊娠前HBsAg+状态与先天性畸形风险之间的关联由丙氨酸转氨酶活性修饰（P交互作用<0.05）。
■孕前HBV感染可能与胎儿畸形有关。这种关联需要进一步调查，以确认它是否是因果关系，并评估HBsAg+计划怀孕的女性的抗病毒治疗是否可能降低胎儿畸形的风险。
■中华人民共和国国家卫生健康委员会,中国；四川省科学技术厅，中国；和中华人民共和国科学技术部。
