WHO Global Clinical Platform: Pregnancy module - Statistical analysis plan


Section 1. Background and objectives

In response to the coronavirus disease (COVID-19) pandemic, the World Health Organization (WHO) launched a global COVID-19 anonymized clinical data platform (WHO Global Clinical Platform) in 2020. 1 It is intended to provide Member States with a standardized approach and platform to collect clinical data to better characterize the natural history of the disease, identify risk factors for severe disease and describe treatment interventions. The use of a single standardized clinical data tool enables aggregation and analysis of clinical data from around the world to gain a better understanding of the disease, inform the public health response and prepare for large-scale clinical trials.
Recognizing the limited evidence on the clinical characteristics of COVID-19 among pregnant and recently pregnant women, the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research (SRH), World Health Organization outbreak group led the effort to develop a pregnancy module to complement the core case report form (Core CRF). The purpose of this clinical data tool parallels that of the Core CRF – to gain a better understanding of the disease among pregnant women, inform the public health response for this special population and prepare for further investigations.
This statistical analysis plan (SAP) provides exploratory objectives which may generate hypotheses for further investigation.
Note: The current pregnancy module SAP should be considered in conjunction with the core SAP for analysis of all non-pregnancy-related outcomes. This SAP has been expanded to include pregnancy-related outcomes (see Fig. 1)