Clinical trial

Neuroimaging Ancillary Study of the IV Iron RAPIDIRON Trial

Name

U32401

Description

As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.

Trial arms

Trial start

2023-02-21

Estimated PCD

2024-02-14

Trial end

2025-02-01

Status

Active (not recruiting)

Treatment

Ferric carboxymaltose

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.

Arms:

RAPIDIRON IV iron intervention arm 1

Iron isomaltoside

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.

Arms:

RAPIDIRON IV iron intervention arm 2

Other names:

Ferric derisomaltose

Ferric Sulfate

As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (\~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.

Arms:

RAPIDIRON active comparator arm

Other names:

Ferric sulphate

Size

184

Primary endpoint

Fetal hippocampal volume

32-35 weeks fetal gestational age

Fetal diffusion parameters: fractional anisotropy (FA)

32-35 weeks fetal gestational age

Fetal diffusion parameters: mean diffusivity

32-35 weeks fetal gestational age

Eligibility criteria

Inclusion Criteria: * For the maternal participant in the parent RAPIDIRON Trial - a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age) * An indication of the pregnant woman's intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits; * Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in this ancillary trial; and * Concurrent participation in the RAPIDIRON-KIDS follow-up study (NCT05504863). Exclusion Criteria: * If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study; * If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 184, 'type': 'ACTUAL'}}

Updated at

2024-05-24

1 organization

3 products

5 indications

Organization

Thomas Jefferson University

Product

Ferric carboxymaltose

Indication

Iron Deficiency Anemia

Indication