Background & objectives : The PregCovid registry was established to document the clinical presentations, pregnancy outcomes and mortality of pregnant and post-partum women with COVID-19. Methods : The PregCovid registry prospectively collects information in near-real time on pregnant and post-partum women with a laboratory-confirmed diagnosis of SARS-CoV-2 from 19 medical colleges across the State of Maharashtra, India. Data of 4203 pregnant women collected during the first wave of the COVID-19 pandemic (March 2020-January 2021) was analyzed. Results : There were 3213 live births, 77 miscarriages and 834 undelivered pregnancies. The proportion of pregnancy/foetal loss including stillbirths was six per cent. Five hundred and thirty-four women (13%) were symptomatic, of which 382 (72%) had mild, 112 (21%) had moderate, and 40 (7.5%) had severe disease. The most common complication was preterm delivery (528, 16.3%) and hypertensive disorders in pregnancy (328, 10.1%). A total of 158 (3.8%) pregnant and post-partum women required intensive care, of which 152 (96%) were due to COVID-19 related complications. The overall case fatality rate (CFR) in pregnant and post-partum women with COVID-19 was 0.8 per cent (34/4203). Higher CFR was observed in Pune (9/853, 1.1%), Marathwada (4/351, 1.1%) regions as compared to Vidarbha (9/1155, 0.8%), Mumbai Metropolitan (11/1684, 0.7%), and Khandesh (1/160, 0.6%) regions. Comorbidities of anaemia, tuberculosis and diabetes mellitus were associated with maternal deaths. Interpretation & conclusions : The study demonstrates the adverse outcomes including severe COVID-19 disease, pregnancy loss and maternal death in women with COVID-19 in Maharashtra, India.

COVID-19 pandemic has affected all age groups globally including pregnant women and their neonates. The aim of the study was to understand outcomes in neonates of mothers with COVID-19 during the first and second waves of COVID-19 pandemic. A retrospective analysis of 2524 neonates born to SARS-CoV-2-infected mothers was conducted during the first wave (n = 1782) and second wave (n = 742) of the COVID-19 pandemic at five study sites of the PregCovid registry in Maharashtra, India. A significant difference was noted in preterm birth, which was higher in the second wave (15.0%, 111/742) compared to the first wave (7.8%, 139/1782) (P < 0.001). The proportion of neonates requiring NICU admission was significantly higher in the second wave (19.0%, 141/742) as compared to that in the first wave (14.8%, 264/1782) (P < 0.05). On comparing regional differences, significantly higher neonatal complications were reported from Mumbai metropolitan region (P < 0.05). During the second wave of COVID-19, birth asphyxia and prematurity were 3.8-and 2.1fold higher respectively (P < 0.001). Neonatal resuscitation at birth was significantly higher in second wave (3.4%, 25/742 vs 1.8%, 32/1782) (P < 0.05). The prevalence of SARS-CoV-2 infection in neonates was comparable (4.2% vs 4.6%) with no significant difference between the two waves.Conclusion: Higher incidence of adverse outcomes in neonates born to SARS-CoV-2-infected mothers in the second wave of COVID-19 as compared to the first wave. Trial registration: PregCovid study is registered with the Clinical Trial Registry of India (CTRI/2020/05/025423, Registered on 28/05/2020). What is Known:• The second wave of COVID-19 was more lethal to pregnant women than the first wave. Newborns are at risk of developing complications. What is New:• Birth asphyxia, prematurity, and neonatal resuscitation at birth were significantly higher in the second wave as compared to those in the first wave of the COVID-19 pandemic in India. Keywords Neonatal complications • NICU • SARS-CoV-2 • Second wave Abbreviations COVID-19 Coronavirus disease 2019 NICU Neonatal intensive care unit SARS-CoV-2 Severe acute respiratory syndrome coronavirus-2 * Rakesh Waghmare

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More than 533 million Coronavirus Disease 2019 (COVID-19) cases and associated 6 million fatalities were reported globally whereas 43 million cases and 0.5 million deaths in India were reported till June 2022. Maharashtra state alone reported about one-third of the total cases of COVID-19 in India in the early period of COVID-19 pandemic. The lack of epidemiological, demographic, and impact data of COVID-19 on pregnant women and newborns, advocated the need for recording and documenting population specific data for clinical management and policy decisions in India. The PregCovid registry was launched in April 2020 by the Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health, Mumbai, in collaboration with the Medical Education and Drugs Department, Government of Maharashtra, and Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital to gain insights into clinical and socio-epidemiological characteristics of pregnant women with lab confirmed COVID-19 and assess its impact on maternal and neonatal outcomes. The registry has collected data of 8428 pregnant and postpartum women with COVID-19 from 19 participating centers across Maharashtra in a near real-time manner. The registry first reported that the delta variant (B.1.617.2) dominant second wave was more lethal (case fatality rate 5.7%) to pregnant and postpartum women than the alpha (0.7%) dominant wave of COVID-19 in India. There was also a higher incidence of moderate to severe cases, intensive care admissions and maternal complications including pre-eclampsia, low birth weight and preterm deliveries during the delta wave. The omicron dominant third wave of the COVID-19 pandemic exhibited a higher transmission rate compared to the previous two waves, causing a surge in cases but minimally impacting adverse outcomes. The registry further analyzed and reported the impact of COVID-19 on pregnant and postpartum women with comorbidities, coinfections, twin pregnancies, and neonatal outcomes, while providing crucial policy inputs to improve maternal and newborn health during the pandemic. The registry model can be replicated at tertiary care hospitals across India to understand various maternal-neonatal outcomes. The evidence generated from PregCovid registry was useful for improved clinical management and also contributed to a policy decision on COVID-19 vaccination in pregnant women in India. The registry envisions a collaboration with similar regional, national and international registries to form an international consortium for data sharing and reporting to promote global policy level interventions and advocates a sustainable and collective response to improve the COVID-19 global vaccination coverage.