Health TrialsbyHealthPanel

Early Antenatal Support for Iron Deficiency Anemia

ConditionsPregnancy RelatedAnemia, Iron DeficiencyAnemia of Pregnancy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton gestation

Gestational age <24 weeks

Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia

Hb<11.0

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferumoxytol

    Drug

    510mg infusion x 2 doses 3-8 days apart

  • Ferrous Sulfate

    Drug

    325mg oral twice daily

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Oral IronActive comparator 1 intervention
Group B: Intravenous IronExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin

Change in hemoglboin at day 90 following treatment initiation

Time frame
90 days

Secondary outcomes

1

Anemia resolution

Percent of participants in each group with Hb\>=11.0 at day 90

Time frame
90 days
2

Anemia at Delivery

Percent of participants in each group with Hb\>=11.0 at delivery

Time frame
9 months
3

Need for additional therapy

Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks

Time frame
9 months
4

Quality of life scale

Linear Analogue Scale Assessment

Time frame
30, 60, 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Auerbach Hematology and Oncology

Collaborator

Source ClinicalTrials.gov
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