To better understand how severe acute respiratory coronavirus-2 (SARS-CoV-2) infection impacts outcomes in women and their neonates during pregnancy and the postpartum period, the World Health Organization (WHO) has developed a standardized research protocol for the investigation of coronavirus disease 2019 (COVID-19) in pregnant women. The protocol addresses key research questions, facilitates systematic and harmonized collection of data and biological specimens, and allows 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 outlines a prospective cohort study investigating the outcomes of pregnant or recently pregnant women infected with SARS-CoV-2 (exposed) compared to pregnant or recently pregnant women not infected with SARS-CoV-2 during pregnancy (unexposed). The purpose of this study is to determine if SARS-CoV-2 infection during pregnancy increases the risk of adverse pregnancy, postpartum or neonatal outcomes. Additionally, the study characterizes 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 pregnancy-related fluids (i.e. amniotic fluid), breast milk 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, infectious disease and prevention measures, and future research protocols. SARS-CoV-2 and pregnancy prospective cohort study Generic protocol: Last List of abbreviations ARDS acute respiratory distress syndrome CIOMS Council for International Organizations of Medical Sciences COVID-19 coronavirus disease 2019 CRF case report form FGR fetal growth restriction GCP good clinical practice GDRP general data protection regulation HRP Bank Special Programme of Research, Development and Research Training in Human Reproduction IDMC Independent Data Monitoring Committee IPC infection prevention and control IRB institutional review board IUT intrauterine transmission LFU loss to follow-up LMICs Low- and middle-income countries MERS Middle East respiratory syndrome MTA material transfer agreement MTCT mother-to-child transmission NICU neonatal intensive care unit RDT rapid diagnostic test RT-PCR reverse transcriptase polymerase chain reaction SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 TORCH toxoplasmosis, rubella, cytomegalovirus, herpes simplex WHO World Health Organization WG working group SARS-CoV-2 and pregnancy prospective cohort study Generic protocol: Last updated 2 December 2020, version 2. 8 Preamble This protocol is one of the WHO protocols for COVID-19 designed to enable the rapid and systematic collection of data in a format that facilitates comparison across different settings. All WHO investigation protocols for COVID-19 are available on the WHO website. Any partner who wishes to use this protocol can do so freely and without charge or obligations. We ask implementing study sites to kindly inform the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)/World Health Organization (WHO) about their implementation of this protocol and to provide a contact point. Please share your information with hrp_covid19pregnancycohort@who.int Implementing partners can opt to manage data onsite or through the central HRP repository subject to local circumstances. A pooled analysis bringing together all consenting and contributing sites will be discussed with sites implementing the study. Sites that agree to pool data under the coordination of WHO/HRP will have the option to independently publish their own data. The analysis of the pooled data will be made available and widely disseminated in collaboration with all contributing sites. All partners will retain control of their site data, regardless of whether or not this data is included in pooled or aggregated analyses. All sites wishing to participate are invited to do so; however, WHO/HRP provides no guaranteed support for study implementation. Technical, financial or capacity limitations may be present. However, since this protocol proposes a study design that can be adapted to allow for smaller studies (see Appendix D for proposed methodologies), studies that follow the proposed study design may be pooled/aggregated in order to achieve an overall pooled sample size with sufficient statistical power to answer the