Protocol for a Sequential, Prospective Meta-Analysis to Describe COVID-19 in Pregnancy and Newborn Periods

Smith, E. R.; He, S.; Oakley, E. M.; Miller, L.; Tielsch, J. M.

Background. We urgently need answers to basic epidemiological questions regarding COVID-19 infection in pregnant women and newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically appropriate approach to utilize these data to generate answers. Methods. We propose that a sequential, prospective meta-analysis (PMA) is the best approach to rapidly generate policy and practice-oriented guidelines. As the pandemic is rapidly evolving, studies identified retrospectively through a living systematic review will also be invited to participate. The primary analysis will pool data using a two-stage meta-analysis with generic inverse-variance methods. The meta-analyses will be updated as additional data accrues in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. Participating Studies. At the time of publication, there are 19 studies being conducted in 21 countries that prospectively agreed to pool data for this analysis. Among the 19 included studies, ten are COVID-19 registry studies, seven are cohort or surveillance studies, and two are case-control studies. More than 74,000 pregnant women are expected to contribute to the completed analysis. Dissemination: Protocols and updates will be maintained publicly. Results will be shared with key stakeholders including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Scientific publications will be published in open access journals on an ongoing basis.