Early Antenatal Support for Iron Deficiency Anemia

Description

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.

Conditions

Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy

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Study Overview

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Study Details

Study overview

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.

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

Early Antenatal Support for Iron Deficiency Anemia

Condition
Pregnancy Related
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Study Record Dates

2025-12-30