Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods
Authors: Smith Emily R. , Oakley Erin , He Siran , Zavala Rebecca , Ferguson Kacey , Miller Lior , Grandner Gargi Wable , Abejirinde Ibukun-Oluwa Omolade , Afshar Yalda , Ahmadzia Homa , Aldrovandi Grace , Akelo Victor , Tippett Barr Beth A. , Bevilacqua Elisa , Brandt Justin S. , Broutet Natalie , Fernández-Buhigas Irene , Carrillo Jorge , Clifton Rebecca , Conry Jeanne , Cosmi Erich , Delgado-López Camille , Divakar Hema , Driscoll Amanda J. , Favre Guillaume , Flaherman Valerie , Gale Christopher , Gil Maria M. , Godwin Christine , Gottlieb Sami , Bellolio Olivia Hernandez , Kara Edna , Khagayi Sammy , Kim Caron Rahn , Knight Marian , Kotloff Karen , Lanzone Antonio , Le Doare Kirsty , Lees Christoph , Litman Ethan , Lokken Erica M. , Longo Valentina Laurita , Magee Laura A. , Martinez-Portilla Raigam Jafet , McClure Elizabeth , Metz Torri D. , Money Deborah , Mullins Edward , Nachega Jean B. , Panchaud Alice , Playle Rebecca , Poon Liona C. , Raiten Daniel , Regan Lesley , Rukundo Gordon , Sanin-Blair Jose , Temmerman Marleen , Thorson Anna , Thwin Soe Soe , Tolosa Jorge E. , Townson Julia , Valencia-Prado Miguel , Visentin Silvia , von Dadelszen Peter , Waldorf Kristina Adams , Whitehead Clare , Yang Huixia , Thorlund Kristian , Tielsch James M. 
Published: November 2020

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. 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. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.