Effect of iron folic acid with tablet vitamin C compared to iron folic acid with routine verbal advice of vitamin C rich foods on the hemoglobin levels of anemic pregnant women attending a tertiary care hospital in Puducherry: protocol for a pragmatic trial

Abstract

Background: In routine practice, pregnant women are advised to take iron folic acid (IFA) tablets with vitamin C-rich foods. If vitamin C tablets are given instead, there may be an improvement in the hemoglobin levels of pregnant women. The study aims to find the effectiveness of IFA tablet with vitamin C tablet compared to IFA tablet with verbal advice of vitamin C rich foods, over 6 weeks, on the hemoglobin levels of anemic pregnant women (13-33 weeks) attending a tertiary care hospital in Puducherry. Methods: A pragmatic trial will be conducted in the antenatal OPD of a hospital in Puducherry. Anemic pregnant women will be consecutively recruited until a sample size of 86 is attained. Permuted block randomization and allocation concealment will be used. After eligibility assessment, participants will be randomly assigned two arms. The intervention arm will receive IFA tablets with vitamin C tablets, while the control arm will be advised to take IFA tablets with vitamin C-rich food. Participants will be followed up at 6 weeks. The intention-to-treat approach will be used. Linear regression will be performed followed by multivariable linear regression to adjust for confounding variables. Conclusions: This study protocol is designed to investigate whether the hemoglobin status and control of anemia in anemic mothers can be improved by giving IFA tablets with vitamin C tablets in routine practice, rather than verbal advice to take IFA tablets with vitamin C-rich foods.