Objectives: Convalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. Design: Open-label, parallel-arm, phase II, multicentre, randomized controlled trial. Setting: Thirty-nine public and private hospitals across India. Participants: Hospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air). Intervention: Participants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome Measure: Composite of progression to severe disease (PaO2/FiO2<100) or all-cause mortality at 28 days post-enrolment. Results: Between 22 nd April to 14 th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. Interpretation: CP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.
Introduction: Gestational Diabetes Mellitus is the development of carbohydrate intolerance of variable severity with onset or first recognition during pregnancy. Many studies had suggested that an elevated serum ferritin level in maternal blood in early as well as mid-pregnancy is an independent risk factor for development of GDM. In the present study we aim to find the association of serum ferritin levels with serum iron and Hb% in the GDM patients at the time of delivery and also correlate it with cord blood Hb% and iron levels of the new born. Material and Methods: The study group was composed of 50 diagnosed cases of GDM and the control group comprised of age matched 50 cases of normal pregnancy. Maternal blood was used to measure mother's hemoglobin, iron levels, serum ferritin and hsCRP. Cord blood sample was used to estimate hemoglobin and iron levels of the newborns. Results: Our study shows that in the GDM cases the level of serum ferritin was significantly higher (p <0.001) than in the non GDM controls at the time of delivery. Cord blood hemoglobin is negatively correlated with maternal serum ferritin levels in GDM. Conclusion: Elevated serum ferritin level in GDM is a marker of inflammation due to increased ROS production caused by iron overload. This oxidative stress might affect the placental iron transfer to the fetus and fetal Hb synthesis
Introduction: Insulin resistance during pregnancy is associated with adverse effects on foetal and maternal health, including macrosomia, congenital malformations, perinatal mortality and pre-eclampsia. A 100 g Oral Glucose Tolerance Test (OGTT) is recommended by World Health Organisation (WHO) as the diagnostic test for Gestational Diabetes Mellitus (GDM). However, the inconvenience caused to the pregnant females due to time consuming and cumbersome multi-invasive procedure for performing OGTT has prompted the exploration of an alternative method. Aim: To ascertain whether Glycated Haemoglobin (HbA1c) can be used instead of OGTT for diagnosis of GDM. Materials and Methods: It was a case-control study which was conducted for one year from June 2012 to May 2013. In this study, 200 pregnant females with gestational age from 22-40 weeks underwent Fasting Blood Sugar (FBS), Glucose Challenge Test (GCT) with 50 g glucose load, OGTT and HbA1c investigations. Results: The mean HbA1c of Group 1 with GDM was 5.29±0.68% and mean HbA1c of Group 2 without GDM was 4.83±0.46%. At the HbA1c cut-off of ≥5.85%, 18% of GDM patients were identified with specificity of 97%. A higher HbA1c cut-off of ≥5.95% showed sensitivity and specificity of 16.3% and 70%, respectively. An arbitrary cut-off of ≥5.85% would have diagnosed only 18% of patients with GDM with reasonable specificity. According to this study, 88% of GDM cases stayed undiagnosed by HbA1c at a cut-off of ≥5.85%. Hence, it can play only a supplemental role to OGTT in diagnosing GDM. Conclusion: On the basis of the present study, HbA1c can be used as a supplemental investigation in addition to OGTT for confirmation of GDM in pregnant females. Only drawback was the lack of fixed HbA1c cut-off for diagnosing GDM.
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