ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

BackgroundFew large, cohort studies report data on individual’s maternal, fetal, perinatal, and neonatal outcomes associated with SARS-CoV-2 infection in pregnancy. We report outcomes from a collaboration formed early during the pandemic between the investigators of two registries, the UK and global Pregnancy and Neonatal outcomes in COVID-19 (PAN-COVID) study and the US American Academy of Pediatrics Section on Neonatal Perinatal Medicine (AAP SONPM) National Perinatal COVID-19 Registry.MethodsPAN-COVID (suspected or confirmed SARS-CoV-2 infection at any stage in pregnancy) and the AAP SONPM registry (positive maternal testing for SARS-CoV-2 from 14 days before delivery to 3 days after delivery) studies collected data on maternal, fetal, perinatal and neonatal outcomes. PAN-COVID results are presented as all inclusions and those with confirmed SARS-CoV-2 infection only.ResultsWe report 4004 women in pregnancy affected by suspected or confirmed SARS-CoV-2 infection (1606 from PAN-COVID and 2398 from the AAP SONPM) from January 1st 2020 to July 25th 2020 (PAN-COVID) and August 8th (AAP SONPM). For obstetric outcomes in PAN-COVID and AAP SONPM, respectively, maternal death occurred in 0.5% and 0.17%, early neonatal death in 0.2% and 0.3%, and stillbirth in 0.50% and 0.65% of women. Delivery was pre-term (<37 weeks gestation) in 12% of all women in PAN-COVID, in 16.2% of those women with confirmed infection in PAN-COVID and 16.2% of women in AAP SONPM. Very preterm delivery (< 27 weeks’ gestation) occurred in 0.6% in PAN-COVID and 0.7% in AAP SONPM.Neonatal SARS-CoV-2 infection was reported in 0.8% of PAN-COVID all inclusions, 2.0% in PAN-COVID confirmed infections and 1.8% in the AAP SONPM study; the proportions of babies tested were 9.5%, 20.7% and 87.2% respectively.The proportion of SGA babies was 8.2% in PAN-COVID all inclusions, 9.7% in PAN-COVID confirmed infection and 9.6% in AAP SONPM. Gestational age adjusted mean z-scores were −0.03 for PAN-COVID and −0.18 for AAP SONPM.ConclusionsThe findings from the UK and US SARS-CoV-2 in pregnancy registries were remarkably concordant. Pre-term delivery affected a higher proportion of women in pregnancy than expected from historical and contemporaneous national data. The proportions of women affected by stillbirth, small for gestational age infants and early neonatal death were comparable to historical and contemporaneous UK and US data. Although maternal death was uncommon, the proportion was higher than expected from UK and US population data, likely explained by under-ascertainment of women affected by milder and asymptomatic infection in pregnancy. The data presented support strong guidance for enhanced precautions to prevent SARS-COV-2 infection in pregnancy, particularly in the context of increased risks of preterm delivery and maternal mortality, and for priority vaccination of women planning pregnancy.What is known about SARS-COV-2 infection in pregnancy and neonates?Cohort, population surveillance studies and living systematic reviews have included limited numbers of women in pregnancy affected by COVID-19 and report that most women and infants had good outcomes.What this study addsPreterm deliveries occurred in a high proportion of women participating in these two registries in comparison to contemporaneous and historical national data in the UK and US. The majority of preterm deliveries occurred late preterm (between 32+0 and 36+6 weeks’ gestation).SARS-COV-2 infection in pregnancy did not appear to be associated with a clinically significant effect on the rate of stillbirth, fetal growth, or neonatal outcomes.Although maternal death was uncommon, the proportion was higher than expected from UK and US population data, likely explained by under-ascertainment of women affected by milder and asymptomatic infection in pregnancy.

Current Controlled Trials ISRCTN11392629.

What are the novel findings of this work? Preterm delivery occurred in a higher proportion of women with SARS-CoV-2 infection in the PAN-COVID and AAP-SONPM registries compared to contemporaneous and historical national data from uninfected women in the UK and USA. The majority of preterm deliveries occurred between 32 + 0 and 36 + 6 weeks' gestation. SARS-CoV-2 infection in pregnancy did not appear to be associated with a clinically significant effect on fetal growth, adverse neonatal outcome or the rate of stillbirth. Although maternal death was uncommon, the rate was higher than expected based on UK and USA population data, which is likely explained by underascertainment of women affected by milder or asymptomatic infection in pregnancy in the PAN-COVID study, although not in the AAP-SONPM study. What are the clinical implications of this work? Pregnant women should be counseled that SARS-CoV-2 infection increases the risk of preterm delivery but not stillbirth, early neonatal death or a small baby. Healthcare providers should recommend SARS-CoV-2 vaccination in pregnant women and women planning pregnancy, alongside enhanced social distancing.

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