NCT04278651 Early Antenatal Support for Iron Deficiency Anemia
| NCT ID | NCT04278651 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Thomas Jefferson University |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2021-09-29 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 effects.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04278651 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04278651 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04278651 currently recruiting?
Yes, NCT04278651 is actively recruiting participants. Contact the research team at rupsa.boelig@jefferson.edu for enrollment information.
Where is the NCT04278651 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04278651 clinical trial?
NCT04278651 is sponsored by Thomas Jefferson University. The trial plans to enroll 80 participants.