Evaluation of Neonatal Outcome (Major Congenital Malformation) in First Trimester Pregnant Women with SARS-CoV-2 Infection: A Prospective Cohort Study

Introduction: Coronavirus Disease 2019 (COVID-19) infection has been difficult to control despite advancements in medical science. Many short and long-term complications following COVID-19 infection are still being observed. The hypoxaemia episodes occurring in the first trimester of pregnant women and their potential role in causing congenital malformations in newborns remain unclear. Limited information is available regarding the effects of Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19) during the first trimester of pregnancy and its association with the risk of developing Major Congenital Malformations (MCMs). Aim: To compare the development of congenital malformations in pregnant women who tested SARS-CoV-2 positive and those who tested negative during the first trimester of pregnancy. Materials and Methods: A prospective cohort study was conducted in a small town in the Hooghly district of West Bengal between January 2021 and December 2021. Two nursing homes were selected for sample collection, with approximately 100 patients per centre. The study included 100 pregnant women in their first trimester who tested SARS-CoV-2 positive and another 100 pregnant women in their first trimester who tested negative. An unpaired t-test was performed to analyse the association between the development of MCMs in both groups. Results: The mean maternal age was comparable between the COVID-19-exposed group (24.6 years) and the nonexposed group (25.2 years). The proportions of primigravida and multigravida women were also similar in both groups (62% vs. 64% primigravida, respectively). The odds ratio for MCMs in the COVID-19-exposed group was 0.49, indicating a lower likelihood compared to the non-exposed group. The average Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability/response), Activity (muscle tone), and Respiration (breathing effort) (APGAR) scores at 1 and 5 minutes were slightly higher in the exposed group (7.01 and 7.45) than in the non-exposed group (6.8 and 7.28), though the differences were not statistically significant (p=0.28 and p=0.50, respectively). Conclusion: The present study concludes that there is no evidence of increased risk of MCMs associated with firsttrimester maternal SARS-CoV-2 infection. Overall, the findings do not support any major teratogenic effects resulting from maternal COVID-19 infection in early pregnancy.