Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial

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)

Conditions

• Iron Deficiency Anemia
• Infant, Low Birth Weight
• Anemia of Pregnancy

Interventions

DRUG

Ferric carboxymaltose

Pregnant participants randomized to intervention arm 1 will receive a single dose of ferric carboxymaltose having 1000mg of iron if they weigh over 50kg. If a participant is under 50kg, they will receive a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This will be given ideally immediately after randomization, sometime between 14 weeks and 17 weeks of pregnancy.

DRUG

Iron isomaltoside

Pregnant participants randomized to intervention arm 1 will receive a single dose of iron isomaltoside having 1000mg of iron if they weigh over 50kg. If a participant is under 50kg, they will receive a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This will be given ideally immediately after randomization, sometime between 14 weeks and 17 weeks of pregnancy.

DRUG

Ferric Sulfate

Pregnant participants randomized to the oral iron arm will be given 200 ferrous sulphate tablets with 60mg elemental iron each, immediately after randomization, and instructed to take two per day (one in the morning and one at night) throughout the remainder of their pregnancy.

Sponsors & Collaborators

• Children's Investment Fund Foundation

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

• S. Nijalingappa Medical College

  collaborator UNKNOWN

• Raichur Institute of Medical Sciences

  collaborator UNKNOWN

• Sawai Mansingh Medical College

  collaborator OTHER_GOV

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Richard Derman, MD, MPH · Thomas Jefferson University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2023-12-14

Completion

2024-01-21

Countries

• India

Study Locations