Pregnancy RelatedPhase 4EASI-ANCT04278651
Early Antenatal Support for Iron Deficiency Anemia
A Phase 4 study testing Ferumoxytol and Ferrous Sulfate in people with Pregnancy Related and Anemia, Iron Deficiency, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy
- What is being tested?
- Ferumoxytol and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Rupsa C Boelig, MD, rupsa.boelig@jefferson.edu
About this study
Official title: Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
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.
Read the detailed description
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.
- Being tested
- Ferumoxytol, Ferrous Sulfate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
510mg infusion x 2 doses 3-8 days apart
Ferrous SulfateDrug
325mg oral twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron | Active comparator | 325mg oral iron (ferrous sulfate) twice daily Receives: Drug: Ferrous Sulfate |
| Intravenous Iron | Experimental | 510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose. Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
Change in hemoglboin at day 90 following treatment initiation
Measured: 90 days
Secondary outcomes (9)
Anemia resolution
Percent of participants in each group with Hb>=11.0 at day 90
Measured: 90 days
Anemia at Delivery
Percent of participants in each group with Hb>=11.0 at delivery
Measured: 9 months
Need for additional therapy
Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks
Measured: 9 months
Quality of life scale
Linear Analogue Scale Assessment
Measured: 30, 60, 90 days
Adherence
adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts
Measured: 90 days
Need for post partum transfusion
Incidence of transfusion after delivery/post partum
Measured: 9 months
Neonatal outcomes: cord blood iron indices
Hb, ferritin, total iron saturation
Measured: 9 months
Neonatal outcomes: birth weight
birth weight (grams)
Measured: 9 months
Neonatal outcomes gestational age of delivery (weeks)
gestational age of delivery (weeks)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start29 Sep 2021
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Auerbach Hematology and Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278651
- Sponsor's protocol ID
- 19G.929
- Acronym
- EASI-A
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT04278651
- Acronym / sponsor ID
- EASI-A / 19G.929
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Auerbach Hematology and Oncology
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Oral Iron | Active comparator | Drug: Ferrous Sulfate325mg oral iron (ferrous sulfate) twice daily |
| Intravenous Iron | Experimental | Drug: Ferumoxytol510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton gestation
- Gestational age <24 weeks
- Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia
- Hb<11.0
- Ferritin<30 and/or total iron saturation <20
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferumoxytol510mg infusion x 2 doses 3-8 days apart | Drug | Intravenous Iron |
| Ferrous Sulfate325mg oral twice daily | Drug | Oral Iron |
Primary outcome
Change in Hemoglobin
Time frame: 90 days
Change in hemoglboin at day 90 following treatment initiation
9 secondary outcomes
Anemia resolution
Time frame: 90 days
Anemia at Delivery
Time frame: 9 months
Need for additional therapy
Time frame: 9 months
Quality of life scale
Time frame: 30, 60, 90 days
Adherence
Time frame: 90 days
Need for post partum transfusion
Time frame: 9 months
Neonatal outcomes: cord blood iron indices
Time frame: 9 months
Neonatal outcomes: birth weight
Time frame: 9 months
Neonatal outcomes gestational age of delivery (weeks)
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferumoxytol and Ferrous Sulfate in people with Pregnancy Related and Anemia, Iron Deficiency, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rupsa C Boelig, MD (215-955-9196, rupsa.boelig@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.