Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWomen and Infants Hospital of Rhode Island
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women between the ages of 18-45
Singleton gestation
Iron-deficiency anemia (serum ferritin <30ng/mL and Hb<11 g/dL)
At 13-30 weeks gestation
Disqualifiers
Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
Multiple gestation
Inability or unwillingness to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric derisomaltose
DrugParticipants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
Ferrous sulfate
Drug325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: IV IronExperimental treatment 1 intervention
Group B: Oral IronActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of maternal anemia (hgb<11mg/dL) at delivery
Hemoglobin \<11mg/dL on admission to inpatient obstetrics unit for labor and delivery
Time frame
Within 24 hours of admission to inpatient obstetrics unit for delivery of infantSecondary outcomes
1
Concentration of maternal hemoglobin at delivery
Hemoglobin on admission to inpatient obstetrics unit for labor and delivery
Time frame
Within 24 hours of admission to inpatient obstetrics unit for delivery of infant2
Rate of maternal blood transfusion at delivery
Maternal blood transfusion from delivery to 7 days postpartum
Time frame
Delivery to 7 days postpartum3
Concentration of maternal ferritin at delivery
Maternal ferritin on admission to inpatient obstetrics unit for labor and delivery
Time frame
Within 24 hours of admission to inpatient obstetrics unit for delivery of infant4
Concentration of maternal hemoglobin postpartum day 1
Maternal hemoglobin on postpartum day 1
Time frame
On day after participant delivered her infant; postpartum day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Women and Infants Hospital of Rhode Island
Lead sponsor
Hasbro Children's Hospital
Collaborator
University of Michigan
Collaborator
Washington University School of Medicine
Collaborator
University of Utah
Collaborator
University of Alabama at Birmingham
Collaborator
Oregon Health and Science University
Collaborator
GNP Research at Heme-on-Call
Collaborator
Source ClinicalTrials.gov