Pregnancy and neonatal outcomes of COVID-19 – co-reporting of common outcomes from the PAN-COVID and AAP SONPM registry

Background Few 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. Methods PAN-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. Results We 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. Conclusions The 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 adds Preterm 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. ### Competing Interest Statement Acknowledgements PAN-COVID was funded by the UK National Institute for Health Research and supported by UK Clinical Research Network, Dr Nigel Simpson and the Urgent Public Health committee. EM was funded by an NIHR Academic Clinical Lecturer award. The AAP SONPM was funded by the University of Florida College of Medicine Division of Neonatology and by the in-kind contributions of participating centres. We are grateful to Professor Helen Ward, Imperial College, for her comments on this manuscript. The Imperial NIHR Biomedical Research Centre supported this study. ### Clinical Trial ISRCTN68026880 ### Funding Statement The PAN-COVID registry is funded by the United Kingdom Research Institute (UKRI) and National Institute of Health and Research (NIHR) through COVID-19 Rapid Response Call 2, grant reference MC_PC 19066 The AAP SONPM Registry is funded by the University of Florida College of Medicine Division of Neonatology. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: North West - Haydock Research Ethics Committee, 20/NW/0212. University of Florida IRB. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Anonymised data will be made available via the HDRUK portal after study completion in September 2021.