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.

Abstract

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 grams), 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 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy

The weight percentiles of singleton full-term pregnant women by gestational week and risks of low birth weight or macrosomia in those outsides: a real word data analysis of 32 hospitals

“…We found the weight percentiles by GW could be used to estimate the risk of full-term LBW or macrosomia (OBW) during pregnancy, both LBW and macrosomia were prevalent and associated with increased risks of perinatal morbidity and mortality [24][25][26][27][28].This study showed more frequency of maternal weight under 10th percentile during pregnancy was higher risk of LBW and lower risk of OBW, in contrast more frequency of maternal weight over 90th percentile during pregnancy was lower risk of LBW and higher risk of OBW, but we didn't nd similar report. Many previous reported that inappropriate amount or rate of GWG were associated with adverse pregnancy outcomes including LBW and macrosomia [2,29,30], and low or excess pre-pregnancy BMI, gestational diabetes mellitus, and maternal anemia also increased the risk of LBW or macrosomia [31][32][33][34][35][36][37], this paper also showed these factors were associated with LBW or OBW. Furthermore, maternal age, abnormal reproductive history, assisted reproductive, scarred uterus, parity, delivery mode, and infant sex were considered determinant factors of LBW or OBW, which were consistent with the previous reports [38 -42].…”