Study design, setting and population
anaemia, hypersensitivity, infections
ANAEMIA, HYPERSENSITIVITY, INFECTIONS, MULTIPLE ALLERGIES
A single-centre, open-label, randomised, comparative trial was conducted between July 2017 and February 2020 at the Department of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Denmark. The department employed routine screening for ID and anaemia in the first trimester by measuring Hb and ferritin levels. ID was defined as a ferritin level < 30 µg/L—a threshold with good diagnostic accuracy for determining low storage iron [Participants were randomly assigned to receive either a single dose of IV iron (ferric derisomaltose [FDI], also known as iron isomaltoside; MonoferKey inclusion criteria included: women aged ≥ 18 years; pregnant in the second trimester (gestational age 14–21 weeks, inclusive); persistent ID (ferritin < 30 µg/L) after four weeks of treatment with oral iron. Exclusion criteria included multiple pregnancies, a history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs, active infections, and recent red blood cell (RBC) transfusion. All randomised participants had four scheduled follow-up visits at 3, 6, 12 and 18 weeks post baseline.