Department of Health Management, International Institute of Health Management Research, New Delhi, India
Director of International Institute of Health Management Research, New Delhi, India.
BMJ Open. 2022 Feb 24;12(2):e055377. doi: 10.1136/bmjopen-2021-055377.
Poor pregnancy and neonatal outcomes in infants born to COVID-19 positive mothers have been reported, but there is insufficient evidence regarding subsequent growth and development of these children. Our study aims to explore the effect of in-utero exposure to SARS-CoV-2 on pregnancy outcomes and growth and development of infants.
A multicentric ambispective cohort study with comparison group (1:1) will be conducted at six sites. A total of 2400 participants (exposure cohort, n=1200; comparison cohort, n=1200), ie, 400 participants from each site (200 retrospectively; 200 prospectively) will be included. Exposure cohort will be infants born to women with documented COVID-19 infection anytime during pregnancy and comparison cohort will be infants born to women who did not test positive for SARS-CoV-2 anytime during pregnancy. All infants will be followed up till 1 year of age. Anthropometric measurement, age of attainment of developmental milestones and clinical examination findings will be recorded at each follow-up. Data regarding possible cofactors affecting the outcomes will be collected from both groups and adjusted for during analysis. The two groups will be compared for prevalence of every variable considered in the study. Relative risk, attributable and population attributable risks will be calculated. All risk factors with p<0.1 on bivariate analysis will be subjected to multiple logistic regression analysis. A final multivariable model will be developed by including the statistically significant risk factors.
The study has been approved by the Institutional Review Board of IIHMR Delhi (IRB/2021-2022/006) and will be required to be approved at all participating study sites. The study is scheduled from September 2021 to August 2023. Data from retrospective cohort will be reported by August 2022. All participants will provide written informed consent. We plan to publish our results in a peer-reviewed journal and present findings at academic conferences.
已有研究报道，感染新冠病毒的孕妇所分娩的婴儿妊娠结局和新生儿结局较差，但关于这些婴儿随后的生长发育情况，目前证据不足。本研究旨在探讨 SARS-CoV-2 宫内暴露对妊娠结局及婴儿生长发育的影响。
本研究为多中心前瞻性队列研究，设有对照组（1:1），共纳入 6 个研究地点的 2400 名参与者（暴露组 1200 名，对照组 1200 名），即每个地点纳入 400 名参与者（回顾性 200 名，前瞻性 200 名）。暴露组为孕妇在妊娠期间任何时间确诊 COVID-19 感染所分娩的婴儿，对照组为孕妇在妊娠期间任何时间 SARS-CoV-2 检测结果均为阴性所分娩的婴儿。所有婴儿将随访至 1 岁。每次随访时记录体格测量、发育里程碑的获得年龄和临床检查结果。将从两组中收集可能影响结局的所有相关因素数据，并在分析中进行调整。将比较两组研究中考虑的所有变量的患病率。将计算相对风险、归因风险和人群归因风险。所有单因素分析中 p<0.1 的危险因素将进行多因素逻辑回归分析。通过纳入统计学上有意义的危险因素，建立最终的多变量模型。
本研究已获得 IIHMR 德里分校机构审查委员会的批准（IRB/2021-2022/006），并将在所有参与研究的地点获得批准。本研究于 2021 年 9 月至 2023 年 8 月进行。回顾性队列的数据将在 2022 年 8 月前报告。所有参与者均需签署书面知情同意书。我们计划在同行评议期刊上发表研究结果，并在学术会议上展示研究发现。
