Data_Sheet_1_Cesarean Section or Vaginal Delivery to Prevent Possible Vertical Transmission From a Pregnant Mother Confirmed With COVID-19 to a Neonate: A Systematic Review.DOCX

Background: The impact of delivery mode on the infection rates of Coronavirus disease 2019 (COVID-19) in the newborn remains unknown. We aimed to summarize the existing literature on COVID-19 infection during pregnancy to evaluate which mode of delivery is better for preventing possible vertical transmission from a pregnant mother confirmed with COVID-19 to a neonate.
Methods: We performed a comprehensive literature search of PubMed, Embase, Cochrane Library, Web of Science, Google Scholar, and the Chinese Biomedical Literature database (CBM) from 31 December 2019 to 18 June 2020. We applied no language restrictions. We screened abstracts for relevance, extracted data, and assessed the risk of bias in duplicate. We rated the certainty of evidence using the GRADE approach. The primary outcome was severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positivity in neonates born to mothers with confirmed COVID-19 following different delivery modes. Secondary outcomes were neonatal deaths and maternal deaths. This study is registered with PROSPERO, CRD42020194049.
Results: Sixty-eight observational studies meeting inclusion criteria were included in the current study, with no randomized controlled trials. In total, information on the mode of delivery, detailed neonatal outcomes, and SARS-CoV-2 status were available for 1,019 pregnant women and 1,035 neonates. Six hundred and eighteen (59.71%) neonates were born through cesarean section and 417(40.29%) through vaginal delivery. Probable congenital SARS-CoV-2 infections were reported in 34/1,035 (3.29%) neonates. Of babies born vaginally, 9/417 (2.16%) were tested positive compared with 25/618 (4.05%) born by cesarean. Of babies born vaginally, 0/417 (0.00%) neonatal deaths were reported compared with 6/618 (0.97%) born by cesarean. Of women who delivered vaginally, 1/416 (0.24%) maternal deaths were reported compared with 11/603 (1.82%) delivered by cesarean. Two women died before delivery. Sensitivity analyses and subgroup analyses showed similar findings.
Conclusions: The rate of neonatal COVID-19 infection, neonatal deaths, and maternal deaths are no greater when the mother gave birth through vaginal delivery. Based on the evidence available, there is no sufficient evidence supporting that the cesarean section is better than vaginal delivery in preventing possible vertical transmission from a pregnant mother confirmed with COVID-19 to a neonate. The mode of birth should be individualized and based on disease severity and obstetric indications. Additional good-quality studies with comprehensive serial tests from multiple specimens are urgently needed.
Study registration: PROSPERO CRD42020194049.

研究背景：分娩方式对新型冠状病毒肺炎（Coronavirus Disease 2019, COVID-19）在新生儿中的感染率的影响目前尚不明确。本研究旨在汇总妊娠期新型冠状病毒感染的现有文献，以评估对于确诊COVID-19的孕妇，何种分娩方式更有助于预防可能发生的母婴垂直传播。
研究方法：本研究于2019年12月31日至2020年6月18日期间，对PubMed、Embase、Cochrane图书馆、Web of Science、Google Scholar及中国生物医学文献数据库（Chinese Biomedical Literature database, CBM）进行了全面的文献检索，未设置语言限制。由两名研究者独立筛选文献摘要以评估相关性、提取数据，并重复进行偏倚风险评估。采用推荐分级的评估、制定与评价（Grading of Recommendations Assessment, Development and Evaluation, GRADE）方法对证据质量进行分级。本研究的主要结局指标为不同分娩方式下，确诊COVID-19孕妇所分娩新生儿的严重急性呼吸综合征冠状病毒2（severe acute respiratory syndrome coronavirus 2, SARS-CoV-2）检测阳性率；次要结局指标为新生儿死亡率与孕产妇死亡率。本研究已在PROSPERO注册，注册号为CRD42020194049。
研究结果：本研究共纳入符合纳入标准的68项观察性研究，未纳入随机对照试验。最终共纳入1019名孕妇及1035名新生儿，涵盖分娩方式、详细新生儿结局及SARS-CoV-2感染状态相关信息。其中618名（59.71%）新生儿经剖宫产分娩，417名（40.29%）经阴道分娩。共34/1035（3.29%）名新生儿报告疑似先天性SARS-CoV-2感染。阴道分娩组新生儿的SARS-CoV-2检测阳性率为9/417（2.16%），剖宫产组为25/618（4.05%）。阴道分娩组无新生儿死亡病例，剖宫产组新生儿死亡率为6/618（0.97%）。阴道分娩组孕产妇死亡率为1/416（0.24%），剖宫产组为11/603（1.82%）。另有2名孕妇在分娩前死亡。敏感性分析与亚组分析结果均与上述结论一致。
研究结论：经阴道分娩的孕妇，其新生儿COVID-19感染率、新生儿死亡率及孕产妇死亡率均未显著升高。基于现有证据，尚无充分依据支持剖宫产在预防确诊COVID-19孕妇向新生儿发生母婴垂直传播方面优于阴道分娩。分娩方式应遵循个体化原则，结合孕妇病情严重程度及产科指征确定。亟需开展更多高质量、采用多标本连续检测的研究。
研究注册：PROSPERO CRD42020194049。