A Prospective Study on the Impact of COVID-19 Vaccination on Fetomaternal Outcomes (Code-T0087)

Introduction: The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, emerged in Wuhan, China, in late 2019 and rapidly became a global health emergency. On March 11, 2020, the World Health Organization (WHO) officially declared it a pandemic. Pregnant and non-pregnant women were found to have similar susceptibility to COVID-19 infection. However, due to physiological and immunological adaptations during pregnancy, pregnant women were at a higher risk of severe complications, including increased hospitalization rates, intensive care unit (ICU) admissions, and the need for mechanical ventilation.

Aim and Objectives: This study aimed to evaluate the impact of COVID-19 vaccination on fetomaternal outcomes and to analyze the association between coagulation parameters, anti-SARS-CoV-2 antibody levels, and pregnancy outcomes. The specific objectives were:

1. Compare fetomaternal outcomes in vaccinated and unvaccinated pregnant women.
2. Assess the coagulation profiles of pregnant women vaccinated against COVID-19.
3. Analyze differences in coagulation profiles between vaccinated and unvaccinated pregnant women.
4. Investigate the correlation between coagulation profiles, previous COVID-19 infection, and anti-SARS-CoV-2 antibody levels.

Methodology: A prospective case-control study was conducted in the Department of Obstetrics and Gynecology at Sir Sunder Lal Hospital. The study involved 400 pregnant women, comprising 200 vaccinated and 200 unvaccinated participants. The research spanned 18 months, and inclusion criteria required all pregnant women visiting the department who consented to participate. Women who declined were excluded. Detailed medical histories, including vaccination status and previous COVID-19 infections, were recorded.

Results: The age distribution of participants showed a significant difference between Group A (vaccinated) and Group B (unvaccinated), with the majority falling in the 25–30 years age group (p < 0.001). BMI distribution did not significantly differ between groups, with most participants classified as overweight (p = 0.655). Parity distribution was comparable across groups (p = 0.712). A larger percentage of Group A participants were enrolled at more than 24 weeks of gestation (p = 0.048). Group A also showed a significantly higher proportion of participants with a history of miscarriage (p = 0.018) and a history of COVID-19 infection.

Conclusion: The study concluded that COVID-19 vaccination positively influenced fetomaternal outcomes, as evidenced by elevated anti-SARS-CoV-2 antibody levels in vaccinated pregnant women. Vaccination was associated with reduced risks of complications such as pre-eclampsia and intrauterine growth restriction (IUGR). These findings highlight the importance of ongoing research to better understand the safety and effectiveness of COVID-19 vaccines in pregnant populations.

Keywords: COVID-19 vaccination; Pregnancy outcomes; Maternal health; Neonatal health; Coagulation profiles; SARS-CoV-2 antibodies.