Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial

1811-03347

Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. Anemia rates are among the highest in South Asia, with a recent national survey indicating that over half of pregnant women in India are classified as anemic. For nearly 40 years, India's first-level treatment for anemia in pregnancy has been oral iron; however, side effects, poor adherence to tablet ingestion, and low therapeutic impact are among reasons to consider a new paradigm for treatment of pregnant women with iron deficiency anemia (IDA). Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial is a 3-arm, randomized-controlled trial designed to assess if a single dose of an intravenous (IV) iron formulation, administered early in the second trimester of pregnancy for treatment of moderate IDA, will result in a greater proportion of participants in the IV iron arms achieving a normal hemoglobin concentration in the third trimester when compared to participants randomized to receive oral iron. This trial is also designed to test the hypothesis that the low birth weight (LBW) rate for participants randomized to the IV iron arms will be lower when compared to the LBW rate of those randomly assigned to the oral iron arm. The three arms include two IV iron arms (arm 1 - ferric carboxymaltose, arm 2 - iron isomaltoside, also known as ferric derisomaltose) and an active, comparator arm receiving oral iron, which is the standard of care. This study will be conducted in two states in India - Karnataka and Rajasthan. This study supports the overall goals of the Indian Ministry of Health and Family Welfare for pregnancy care; thus, all study participants will be followed according to the Ministry's antenatal care guidelines, and data will be collected through 42 days post-delivery. (see attached protocol for more detail)

2021-03-15

2023-12-14

2024-01-21

Completed

Early phase I

4368

Inclusion Criteria for Study Consent for Initial Participation: * Pregnant women between 18-40 years of age at time of consent that received education about the study and were capable of giving informed consent; * Hemoglobin concentration of 7 - 10.4 g/dL; * Expressed intent and expectation of remaining in the designated research area during pregnancy and delivering in a facility in or near the research area and remaining in the area to enable study participant and data collection consistent with the research protocol; * Expressed willingness that specifically includes agreement to randomization to the standard care study arm (of oral iron) or to one of the two arms involving treatment with single-dose IV iron. Additional Inclusion Criteria for Randomization and Continued Study Participation: * Iron deficiency anemia, defined for this study as moderate anemia with hemoglobin concentration level between 7 - 9.9 g/dL, serum transferrin saturation (TSAT) \<20%, and/or ferritin \<30 ng/mL; * Presence of a live, singleton, intrauterine fetus and dating ultrasound (at visit #2) that indicates a pregnancy that, at randomization, would be between the beginning of week 14 and prior to 17 weeks 0 days. Exclusion Criteria: * Fetal anomaly, if detectable when an initial ultrasound is done to date the pregnancy (subsequent discovery of a fetal anomaly is not viewed as an exclusion criterion); * History of cardiovascular disease, hemoglobinopathy, or other disease or condition considered a contraindication for treatment, including conditions recommended for exclusion by the manufacturers of oral or IV iron to be used in this study; * Any condition that, in the opinion of the consenting physician, warrants study exclusion.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-arm, randomized-controlled trial involving two intervention arms (two formulations of intravenous iron) and one active, comparator arm (oral iron, standard of care). Pregnant participants will be randomized with a one-to-one-to-one ration to the three study arms.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Oral iron use will not be masked (as tablets will be provided). However, blinding will occur for the two IV iron intervention arms, as participants, primary health center (PHC) staff, and community health center (CHC) infusion teams will only know that participants have been randomly assigned to receive an IV iron infusion without knowing the specific arm and formulation to be used. A pharmacist associated with each CHC performing infusions for the trial will be designated to prepare the randomly assigned IV iron formulation (according to participant weight and manufacturer instructions) on the day of treatment.'}}, 'enrollmentInfo': {'count': 4368, 'type': 'ACTUAL'}}

2024-05-24