Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Age \> 18 years of age

• Ferritin level \< 30 ng/mL

• Singe gestation

• Gestational age up to 36 weeks as iron therapy after this has shown to be not beneficial at time of delivery. We will still plan to treat patients \> 36 weeks but not include them in the final analysis

• Plan to delivery at Arrowhead Regional Medical Center (ARMC)

Locations
United States
California
Arrowhead Regional Medical Center
RECRUITING
Colton
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 900
Treatments
Active_comparator: Intravenous iron
Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.
Placebo_comparator: Oral iron
Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.
Related Therapeutic Areas
Sponsors
Leads: Arrowhead Regional Medical Center

This content was sourced from clinicaltrials.gov