Effect of in utero exposure to SARS-CoV-2 infection on pregnancy outcomes and growth and development of infants: protocol for a multicentre ambispective cohort study in India.

Introduction: 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.

Methods And Analysis: 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.

Ethics And Dissemination: 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.