Generic protocol: a prospective cohort study investigating maternal, pregnancy and neonatal outcomes for women and neonates infected with SARS-CoV-2, 1 November 2022
Version 3.1
Overview
This prospective cohort study is currently being implemented in 9 countries: Argentina, Brazil, Burkina Faso, Chile, Ghana, Kenya, Pakistan, Philippines, Tunisia, and over 15000 pregnant women have been enrolled across the sites.
The purpose of this study is to determine if SARS-CoV-2 infection during pregnancy increases the risk of adverse pregnancy, perinatal, post-partum and neonatal outcomes; and describe pregnancy, perinatal, neonatal and postpartum outcomes amongst women
who have received at least one dose of a COVID-19 vaccine during pregnancy. Additionally, the study will characterize the clinical spectrum of COVID-19 in pregnant women, determine the probability of detecting SARS-CoV-2 RNA in pregnancy-related fluids
(i.e. amniotic fluid), breast milk and tissues; follow clinical outcomes of women and their neonates up to 6 weeks after childbirth; and assess COVID-19 vaccine uptake among pregnant women in the study, along with symptoms and events following
vaccination.
