MedTrace Logo

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

NCT05251493 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-05-15

No results posted yet for this study

Summary

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion.

The goal of this clinical trial:

* Correct IDA with fewer visits and less impact on the healthcare system
* Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.

Conditions

  • Iron Deficiency Anaemia in Childbirth

Interventions

DRUG

Iron Isomaltoside 1000, ferric derisomaltose

iron isomaltoside 20 mg/mL

DRUG

Iron sucrose

iron sucrose 100 mg/mL

Sponsors & Collaborators

  • Saskatchewan Centre for Patient-Oriented Research

    collaborator OTHER

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Ryan Lett, MD, FRCPC · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251493 on ClinicalTrials.gov