Economic burden of out-of-pocket expenditure, productivity cost during pregnancy and COVID-19 impact on household economy in a cohort of pregnant women in Anuradhapura District, Sri Lanka; A study protocol [version 3; peer review: 2 approved]

Background: Investigating the out-of-pocket expenditure (OOPE) associated with maternal health is important since OOPE directly affects the affordability of health services. Global evidence suggests the importance of capturing the productivity cost during pregnancy in terms of absenteeism and presenteeism. Furthermore, the impact of the ongoing COVID-19 pandemic on the household economy needs to be further evaluated as pregnant women are one of the most vulnerable groups. This study aims at determining the economic burden of OOPE, productivity cost, and COVID-19 impact on pregnant women's household economy in a cohort of pregnant women in Anuradhapura District, Sri Lanka. Methods: The study setting is all 22 Medical Officer of Health (MOH) areas in Anuradhapura district, Sri Lanka. The study has three components; a follow-up study of a cohort of pregnant women to assess the magnitude and associated factors of OOPE and to assess the productivity cost (Component 1), a qualitative case study to explore the impact and causes of the OOPE under free health services (Component 2) and a cross-sectional study to describe the effects of COVID-19 outbreak on household economy (Component 3). The study samples consist of 1,573 and 1,460 participants for components one and three, respectively, and 25 pregnant women will be recruited for component two. The data will be analyzed using descriptive, parametric, and non-parametric statistics for the first and third components and thematic analysis for the second component. Discussion: With the lack of evidence on OOPE, productivity loss/cost in terms of maternal health, and COVID-19 impact on household economy in Sri Lanka, the evidence generated from this study would be valuable for policymakers, health care administrators, and health care practitioners globally, regionally, and locally to plan for future measures for reducing the OOPE, productivity loss/cost, and minimizing the economic hardship of the COVID-19 outbreak during pregnancy.