Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
Recruiting
Phase 3
Interventional Study
Iron Deficiency Anaemia in Childbirth
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 50
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 280 (estimated)
- Sponsor
- Saskatchewan Health Authority - Regina Area · Other
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About This Trial
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 b…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18 years of age and over
* Pregnancy with Gestational age ≥13 weeks
* Iron deficiency anemia defined as:
* Hemoglobin less than or equal to 110g/L and
* Serum ferritin less than 30ng/mL or
* Iron Saturation (Iron/TIBC) less than 20%
* Willing to participate and attend all plan…
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