Effectiveness of Hydroxyurea along with standard of care compared to only standard of care on adverse maternal and foetal outcomes: A randomised controlled trial among pregnant women suffering from sickle cell disease in Gujarat, India

Sickle cell disease is an inherited blood disorder characterized by the tendency of red blood cells to become sickle-shaped and block capillaries, leading to vaso-occlusion and anaemia. Pregnant women who have Sickle cell disease (SCD) have an increased risk for adverse maternal, fetal and neonatal outcomes. Despite providing the standard of care, maternal and fetal outcomes have been unfavourable in a variety of clinical settings, even in high-income countries. We propose doing a randomized control academic trial with consenting patients in one arm to receive Hydroxyurea medicine after the first trimester of pregnancy along with standard care and the control arm to receive standard care only. This study will be conducted at Kasturba Maternity Hospital managed by a voluntary organization SEWA-Rural situated in the Jhagadia block of the Bharuch district in Gujarat, India. Jhagadia block has a population of 155,000. Almost 70% of the population is tribal/indigenous. This will be a parallel-group design, double-blind, stratified, randomized controlled trial. The Hydroxyurea medicine will be started as early as possible during the second trimester, and it will be continued up to delivery unless the patient experiences its side effects. The standard antenatal care will be provided as per the clinical protocol of the hospital. Hydroxyurea will be started as per the national guidelines at 10-15 mg/kg/day orally. The primary outcome of interest is 1. Adverse maternal outcome event score per person per month in the intervention group in compared to the control group. 2.   Time to first-time occurrence of severe maternal adverse event. The required sample size based on sample size calculations as per primary outcomes was 39. After calculating loss to follow-up (15%) and MTP/abortion 10% we will need a total of 49 women in a group. We will do a mixed effect regression model and survival analysis to find differences between the groups for primary outcome indicators respectively.