Study Summary
This trial is testing if IV iron therapy is better than oral iron therapy for anemia in pregnancy.
Eligible Conditions
- Iron Deficiency Anemia
- Pregnancy
- Anemia of Pregnancy
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: 9 months
30, 60, 90 days
Quality of life scale
9 months
Anemia at Delivery
Need for additional therapy
Need for post partum transfusion
Neonatal outcomes gestational age of delivery (weeks)
Neonatal outcomes: birth weight
Umbilical Cord Blood
90 days
Adherence
Anemia resolution
Body Weight Changes
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Iron Sucrose
43%Injury, poisoning and procedural complications
37%Gastrointestinal disorders
34%Infections and infestations
26%Musculoskeletal and connective tissue disorders
25%Vascular disorders
25%Nervous system disorders
22%General disorders and administration site conditions
19%Respiratory, thoracic and mediastinal disorders
19%Cardiac disorders
15%Nausea
15%Metabolism and nutrition disorders
13%Investigations
12%Vomiting
12%Diarrhoea
11%Pain in extremity
10%Skin and subcutaneous tissue disorders
8%Arteriovenous fistula site complication
8%Abdominal pain
7%Non-cardiac chest pain
7%Headache
7%Arteriovenous fistula thrombosis
7%Psychiatric disorders
7%Arthralgia
7%Muscle spasms
7%Hypotension
7%Dizziness
6%Dyspnoea
6%Fall
6%Cellulitis
6%Upper respiratory tract infection
6%Hypertension
6%Fluid overload
6%Blood and lymphatic system disorders
5%Anaemia
5%Cardiac failure congestive
5%Cough
5%Hyperkalaemia
4%Angina pectoris
4%Pruritus
3%Pneumonia
3%Acute myocardial infarction
3%Hypoglycaemia
3%Urinary tract infection
2%Sepsis
2%Acute respiratory failure
2%Cardiac arrest
2%Pulmonary oedema
2%Ear and labyrinth disorders
1%Immune system disorders
1%Gastrointestinal haemorrhage
1%Cardio-respiratory arrest
1%Mental status changes
1%Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%Pyrexia
Trial Design
2 Treatment Groups
Oral Iron
1 of 2
Intravenous Iron
1 of 2
Active Control
Experimental Treatment
80 Total Participants · 2 Treatment Groups
Primary Treatment: Ferumoxytol · No Placebo Group · Phase 4
Intravenous Iron
Drug
Experimental Group · 1 Intervention: Ferumoxytol · Intervention Types: DrugOral Iron
Drug
ActiveComparator Group · 1 Intervention: Ferrous Sulfate · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iron
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months
Who is running the clinical trial?
Auerbach Hematology and OncologyUNKNOWN
Thomas Jefferson UniversityLead Sponsor
407 Previous Clinical Trials
135,429 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a baseline hemoglobin level of 9.0 to 11.
Ferritin is less than 30 ng/mL and/or TIBS is less than 20%.
Who else is applying?
What state do they live in?
| Utah | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Thomas Jefferson University Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments