Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05251493
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 planned follow up visits
* Willing to sign informed consent form
* Willing to attend appointments for iron infusion and follow up visits
* Willing to attend all planned bloodwork appointments
Exclusion Criteria:
* Pregnancy GA less than 13 weeks
* History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
* Known serious hypersensitivity to other parental iron products
* Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
* Decompensated liver cirrhosis or active hepatitis
* History of multiple allergies
* Active acute or chronic infections
* Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
* Current participation in any other interventional trial
* Multiple gestation pregnancy
* Significant comorbidities (asthma requiring daily therapy or other lung diseases)
* Heart disease
* Kidney disease
* Rheumatologic disease
* Cancer
* Known hypersensitivity to iron sucrose or any excipients
* Known hypersensitivity to iron isomaltoside or any excipients.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05251493
Study Brief:
Protocol Section:
NCT05251493