increased risk for intensive care unit admission and of receiving mechanical ventilation, but not death (13). Recent estimates indicate a COVID-19 infection fatality rate of 0.68% in the general population (14), while a large study of symptomatic women of reproductive age (15–44 years) in the United States has reported up to a 70% increased risk of death in pregnant women (15). Additionally, although data is not yet peer reviewed, case studies have reported that SARS-CoV-2 infection during pregnancy may increase risk of perinatal complications, including fetal distress, preterm birth and perinatal death (12,16–18). This standardized protocol describes a prospective cohort study investigating the longitudinal course of women with exposure, exposure risk or documented infection with SARS-CoV-2 during their pregnancy. The overarching goal of this study is to gain critical knowledge on how infection with SARS-CoV-2 impacts pregnancy and neonatal outcomes, with the additional aims to understand mother-to-child transmission (MTCT) (if any), viral presence in pregnancy-related body fluids (i.e. amniotic fluid), breast milk and tissues, and the clinical presentation of the disease in pregnant women. Additionally, this protocol includes an option for a case control component to investigate disease severity in pregnancy compared to non-pregnant women with COVID-19. Pooled analyses will be done at global level, and at national or subnational level, subject to priorities of individual partners implementing the protocol. Participation in global analyses is not a prerequisite to implement the protocol. COMMENT: The introduction should be updated with country-specific data on COVID-19 epidemiology and current research findings prior to submission to local/national institutional review boards (IRBs). 3 Problem statement, aims and objectives To better understand how SARS-CoV-2 infection during pregnancy impacts outcomes, the WHO has developed a standardized research protocol for the investigation of COVID-19 in pregnant women. The protocol will address key research questions, facilitate systematic and harmonized collection of data and biological specimens, and allow for data comparison and aggregation across different locations while minimizing potential biases. The protocol is designed to be adapted as needed in each study site, based on resource availability and local circumstances. This protocol is for a prospective cohort study investigating maternal and neonatal outcomes in pregnant women infected with SARS-CoV-2 compared to pregnant women not infected with SARS-CoV-2. The purpose SARS-CoV-2 and pregnancy prospective cohort study Generic protocol: Last updated 2 December 2020, version 11 of this study is to determine if SARS-CoV-2 infection during pregnancy increases the risk of adverse pregnancy or neonatal outcomes. Additionally, this study will characterize the clinical spectrum of COVID-19 in pregnant women, quantify (if any) the rate of in utero/intrapartum/postnatal transmission, determine the incidence of detectable SARS-CoV-2 RNA in amniotic fluid, breast milk, other bodily fluids and tissues, and follow clinical outcomes of women and their newborns up to 6 weeks after childbirth. It is expected that findings from studies implementing this protocol will be published, widely disseminated and used to develop recommendations on the surveillance, management and counselling of women during and after pregnancy, as well as their babies, in the context of the COVID-19 pandemic. Findings related to the implementation of this study protocol will help to inform public health measures, infection disease and prevention measures, and future research protocols. The overall objective is to assess whether SARS-CoV-2 infection during pregnancy increases the risk of adverse clinical, pregnancy, perinatal or neonatal outcomes. 3.1 Definitions Pregnant women: This protocol uses the term “pregnant women” to describe women who are pregnant or in the immediate postpartum period (up to 48 hours following delivery). Perinatal period denotes the time between 22 weeks gestations and 7 days after birth. Neonatal period denotes the first 4 weeks of a newborn's life. Postpartum period denotes the 42 days following delivery/pregnancy termination. 3.2 Outcomes and objectives Adverse outcomes of interest: 1. Maternal and pregnancy outcomes: (e.g. induced abortion, ectopic pregnancy, miscarriage, delivery mode, preterm birth, fetal growth restriction, haemorrhage, maternal morbidity and mortality); 2. Perinatal outcomes: related to the fetus/neonate that occurs after 22 weeks gestation and within 7 days after birth (e.g. stillbirth, admission to the neonatal Intensive care unit (NICU), neonatal mortality within 7 days of life); 3. Neonatal outcomes: following birth up to 4 weeks of life (e.g. neonatal morbidity, infection, mortality); 4. Postpartum outcomes: maternal outcomes (e.g. infection, bleeding, transmission of SARS-CoV-2) up to 6 weeks after delivery; 5. COVID-19 outcomes: (e.g. hospitalization, acute respiratory distress syndrome (ARDS), severity, mortality, viral persistence). The primary objectives of the study are: 1. to analyse if SARS-CoV-2 infection in pregnant women increases the risk of adverse