Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
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)
Phase:
Phase 4
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
Children's Investment Fund Foundation Jawaharlal Nehru Medical College Raichur Institute of Medical Sciences S. Nijalingappa Medical College Sawai Mansingh Medical College