RECRUITING

Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

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

Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.

Official Title

Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Quick Facts

Study Start:2023-01-17
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05462704

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 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women between the ages of 18-45
  2. * Singleton gestation
  3. * Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
  4. * At 13-30 weeks gestation
  5. * Plan to deliver at participating hospital
  1. * Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
  2. * Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
  3. * Multiple gestation
  4. * Inability or unwillingness to provide informed consent
  5. * Inability to communicate with members of the study team, despite the presence of an interpreter
  6. * Planned delivery at a non-study affiliated hospital

Contacts and Locations

Study Contact

Crystal Ware, BSN, CCRP
CONTACT
401-274-1122
cware@wihri.org

Principal Investigator

Methodius Tuuli, MD, MPH, MBA
PRINCIPAL_INVESTIGATOR
Women and Infants Hospital of Rhode Island

Study Locations (Sites)

University of Alabama Medical Center
Birmingham, Alabama, 35401
United States
GNP Research at Heme-on-Call
Miami, Florida, 33143
United States
Michigan University Medical Center
Ann Arbor, Michigan, 48109
United States
Washington University Medical Center
Saint Louis, Missouri, 65105
United States
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, 97239
United States
Hasbro Children's Hospital
Providence, Rhode Island, 02905
United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

  • Methodius Tuuli, MD, MPH, MBA, PRINCIPAL_INVESTIGATOR, Women and Infants Hospital of Rhode Island

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 Date2023-01-17
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-01-17
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Iron Deficiency Anemia
  • Pregnancy