Intravenous Iron Versus Oral Iron for Iron Deficiency Anemia in Pregnancy

This study is looking at whether giving iron through a vein (intravenous Venofer 200 MG Per 10 ML Injection) early in pregnancy works better than taking iron by mouth (oral Ferrous sulfate) for pregnant women with iron deficiency anemia. Iron deficiency anemia means you don't have enough healthy red blood cells because of low iron. The study wants to see if intravenous iron can raise your hemoglobin levels (a protein in red blood cells that carries oxygen) before delivery and reduce the need for blood transfusions. You could join if you are a woman over 18, have low ferritin levels (a protein that stores iron), are pregnant with one baby up to 36 weeks, and plan to deliver at Arrowhead Regional Medical Center (ARMC). The study will measure your hemoglobin and ferritin levels before treatment and again four weeks later, and your hemoglobin level at delivery.

Study design
This is an interventional study, meaning participants will receive a specific treatment. About 900 pregnant women will be randomly assigned to receive either intravenous or oral iron.
What's involved
You would complete a symptom questionnaire, have blood tests for hemoglobin and ferritin before treatment, and then have follow-up visits with symptom checks and lab tests four weeks later and again between 24 and 28 weeks of pregnancy. Your final hemoglobin level will be checked before delivery.
Compensation
Not stated in the trial record.
Follow-up
Your hemoglobin and ferritin levels will be measured four weeks after starting treatment, and your hemoglobin level will be measured at the time of delivery.

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NCT06366698

Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia

UNKNOWN
PHASE3Ages 18+InterventionalTreatment
Arrowhead Regional Medical Center
~900 participants
Updated 2024-04-16 on ClinicalTrials.gov
What's tested:Venofer 200 MG Per 10 ML InjectionFerrous sulfate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemoglobin difference
Measured over Hemoglobin level obtained prior to treatment and then 4 weeks later
+4 more outcomes measured
Iron Deficiency Anemia of Pregnancy

NCT06366698

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrowhead Regional Medical Center

    Colton, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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)

Exclusion

Maternal age \< 18 years of age
Incarcerated patients
Multifetal gestation
Acute liver/kidney disease
Active infections
Known hematological malignancy
Other causes of anemia such as alpha/beta thalassemia, sickle cell disease, Folate/B12 deficiency, and anemia of chronic diseases
Known hypersensitivity with IV iron
Severe symptoms of anemia requiring blood transfusion
  • Hemoglobin differenceHemoglobin level obtained prior to treatment and then 4 weeks later

    Change in hemoglobin level after intervention, larger difference mean more improvement in Hgb

  • Ferritin differenceFerritin level obtained prior to treatment and then 4 weeks later

    Change in ferritin level after intervention, larger difference mean more improvement in ferritin level

  • Delivery HemoglobinObtained at time of delivery

    Comparing pre-delivery hemoglobin levels

  • Rates of blood transfusionAt time of delivery until 6 weeks postpartum

    Comparing rates of blood transfusion at time of delivery between the 2 groups. The number of units transfused will be collected and compared among the groups

  • Symptoms4 weeks

    Comparing number of anemia symptoms before and after treatment. There are 11 anemia symptoms on the questionnaire. Using a Likert scale from 0 (no symptoms) to 5 (severe symptoms) patient mark each one. The score is totaled up and can range from 0-55.