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New treatment option for Pregnancy Related
Official title Early Antenatal Support for Iron Deficiency Anemia
ClinicalTrials.gov ID: NCT04278651
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pregnancy related.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Singleton gestation
- Gestational age \<24 weeks
- Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by:
- Hb\<11.0
- Ferritin\<30 and/or total iron saturation \<20
You likely can't join if
- Sickle cell Disease (NOT sickle cell trait)
- Evidence of acute anemia requiring transfusion or IV iron therapy
- Major congenital or chromosomal anomaly
- Previous use of IV iron in this pregnancy
- Severe cardiac, renal, or liver disease
- Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
See the full eligibility criteria
- Singleton gestation
- Gestational age \<24 weeks
- Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by:
- Hb\<11.0
- Ferritin\<30 and/or total iron saturation \<20
- Sickle cell Disease (NOT sickle cell trait)
- Evidence of acute anemia requiring transfusion or IV iron therapy
- Major congenital or chromosomal anomaly
- Previous use of IV iron in this pregnancy
- Severe cardiac, renal, or liver disease
- Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
- Allergy or contraindication to either study drug
- History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.