RAPIDIRON: Reducing Anaemia in Pregnancy in India-a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries.

BACKGROUND: Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India's anaemia rate is among the highest in the world with India's National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India's Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. METHODS: This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30-34 weeks' gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 g), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. DISCUSSION: The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2020/09/027730. Registered on 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy.

Stress and anxiety in parents of mentally retarded children.

BACKGROUND: Studies comparing the stress perceived by parents of mentally retarded and normal children are limited. AIM: (i) To find whether there exists a difference in the perceived stress between both the parents of mentally retarded children, (ii) to study whether these stresses occur more frequently in parents of mentally retarded children compared with those of normal children, and (iii) to find any correlation between the severity of perceived stressors and the anxiety state of these parents. METHODS: This study was conducted in the Child Guidance Clinic of a tertiary care psychiatry hospital. The study sample, comprising 180 subjects, was categorized as: group A (60 parents of profound to moderately mentally retarded children), group B (60 parents of mild to borderline mentally retarded children) and group C (60 parents of children with normal intelligence), which served as the control group. Each parent was evaluated using the Family Interview for Stress and Coping (FISC) in Mental Retardation, and the Hamilton Anxiety Rating Scale (HARS). RESULTS: Parents in group A had a significantly higher frequency of stressors and level of anxiety as compared to those in groups B and C. A positive correlation was found between the level of anxiety and stressors. CONCLUSION: Multifaceted factors made parents in groups A and B more vulnerable to stress compared with parents in the control group.