RECRUITING

Early Antenatal Support for Iron Deficiency Anemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2021-09-29
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04278651

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Singleton gestation
  2. * Gestational age \<24 weeks
  3. * Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia
  4. * Hb\<11.0
  5. * Ferritin\<30 and/or total iron saturation \<20
  1. * Sickle cell Disease (NOT sickle cell trait)
  2. * Evidence of acute anemia requiring transfusion or IV iron therapy
  3. * Major congenital or chromosomal anomaly
  4. * Previous use of IV iron in this pregnancy
  5. * Severe cardiac, renal, or liver disease
  6. * Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
  7. * Allergy or contraindication to either study drug
  8. * History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

Contacts and Locations

Study Contact

Rupsa C Boelig, MD
CONTACT
215-955-9196
rupsa.boelig@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-29
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-09-29
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Anemia, Iron Deficiency
  • Anemia of Pregnancy