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Intravenózní železo versus perorální železo pro léčbu anémie z nedostatku železa (IDA)

4. listopadu 2026 aktualizováno: Arrowhead Regional Medical Center

Early Intravenous Versus Oral Iron for Ferritin-Defined Iron Deficiency in Pregnancy: A Prospective Comparative Study

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Iron deficiency anemia is a prevalent health concern affecting approximately a quarter of the global population. In specific high-risk subgroups such as pregnancy, the occurrence of anemia is even higher. This condition is associated with adverse outcomes such as increased risks of blood transfusion, longer hospital stays, slower recovery, and depression, along with pregnancy risks such as preterm birth and low birth weight. Furthermore, infants born to iron-deficient mothers are at risk for delayed childhood growth and cognitive development. Preoperative optimization is crucial for improving clinical outcomes, as iron deficiency anemia accounts for over 80% of anemia cases in these patients.

Traditionally, oral (PO) iron supplementation has been the standard approach recommended by the American College of Obstetrics and Gynecology (ACOG) for preventing and addressing iron deficiency due to its simplicity and cost-effectiveness. However, it is marred by poor adherence to therapy and a high incidence of gastrointestinal side effects. While numerous publications have documented the safety and efficacy of intravenous (IV) iron, its utilization remains limited. Currently, IV iron is primarily reserved for patients who exhibit intolerance or an inadequate response to oral therapy. At our institution, we have taken proactive steps by administering IV iron infusions to many of our patients at an earlier gestational age, given the high rate of non-compliance with oral iron therapy. Our hypothesis proposes that individuals with iron deficiency anemia, defined as a serum ferritin level of less than 30 ng/mL (with 92% sensitivity and 98% specificity compared to hemoglobin (Hgb) levels), who receive IV iron infusions, will achieve higher Hgb levels upon admission and experience reduced rates of blood transfusions.

This study aims to assess the impact of IV iron infusions on pregnant patients with iron deficiency anemia. We hope that implementing this study will help improve overall population health. We hypothesize that individuals with iron deficiency anemia who receive IV iron infusions will attain higher Hgb levels at the time of admission and experience reduced rates of blood transfusions at the time of delivery.

After obtaining the patient's consent, they will be allocated into either of the two treatment options. All odd numbers will be in the oral iron group and even numbers enrolled into the IV iron group. We intend to administer Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water, as numerous randomized control trials have demonstrated that increasing the iron dose does not lead to improved efficacy. Venofer 200 mg will be given every other day until the patient reaches their calculated iron deficit. The dose 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. Our target Hgb will be 11.0 g/dL.

Patients will be given a symptom questionnaire at the time of enrollment to fill out. We will analyze the patient's ferritin, iron, total iron binding capacity (TIBC), Hgb level, mean corpuscular volume (MCV), and Hgb electrophoresis, which are routinely obtained on the first visit with prenatal labs. Four weeks after initiating treatment, patients will fill out a symptom and side effect questionnaire, and if on PO iron, their compliance will be assessed. Complete blood count (CBC) and iron studies will be repeated at that time. Other patient information such as admission CBC, post-delivery CBC, height, weight, body mass index (BMI), age, parity, gestational age at delivery, quantitative blood loss, route of delivery, need for blood transfusion, number of IV iron infusions, fetal birth weight, and antepartum/intrapartum/postpartum complications such as diabetes, preeclampsia/eclampsia, chorioamnionitis, and hemorrhage, etc., neonatal intensive care unit (NICU) admission as well as Edinburgh depression screening results, will be obtained from medical records. This information will be used for secondary outcomes analysis and to ensure there are no confounding factors. Statistical comparisons between groups will be performed using the two-way T-test followed by Tukey's test, or post hoc Student-Newman-Keuls tests. A P < .05 will be considered a statistically significant difference among groups.

Typ studie

Intervenční

Zápis (Aktuální)

518

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • California
      • Colton, California, Spojené státy, 92324
        • Arrowhead Regional Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Age > 18 years of age
  • Ferritin level < 30 ng/mL
  • Single gestation
  • 14 0/7 to 34 6/7 weeks of gestation
  • Plan to deliver at Arrowhead Regional Medical Center (ARMC)

Exclusion Criteria:

  • Maternal age < 18 years of age
  • Hgb < 7
  • 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 to IV iron
  • Severe symptoms of anemia requiring blood transfusion

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.

200 mg IV every 2 days until the targeted dose

Ostatní jména:
  • Železo sacharóza
Komparátor placeba: Oral iron

Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.

Take 1 tablet every other day with lemon/orange juice

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hemoglobin difference
Časové okno: Hemoglobin level obtained prior to treatment and then 4 weeks later

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

Hemoglobin level obtained prior to treatment and then 4 weeks later
Ferritin difference
Časové okno: Ferritin level obtained prior to treatment and then 4 weeks later

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

Ferritin level obtained prior to treatment and then 4 weeks later

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Preterm delivery
Časové okno: At the time of delivery

Comparing hemoglobin levels to gestational age at delivery

At the time of delivery
Depression
Časové okno: Duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum

Edinburgh postnatal depression scale at first prenatal visit and postpartum. 10 questions with total score between 0-30. Higher score indicated increase risk for depression.

Duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Birthweight
Časové okno: At time of delivery

Comparing birthweight to hemoglobin levels at time of admission

At time of delivery
Pre-delivery Hemoglobin
Časové okno: Obtained at time of delivery

Comparing pre-delivery hemoglobin levels

Obtained at time of delivery
Symptoms
Časové okno: 4 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.

4 weeks
Rates of blood transfusion
Časové okno: At 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

At time of delivery until 6 weeks postpartum
Persistent anemia
Časové okno: 4 weeks

Comparing the number of patients with Hgb < 10.5 after intervention

4 weeks
Treatment adherence
Časové okno: 4 weeks

Treatment adherence was assessed differently according to the assigned treatment group. In the oral iron group, adherence was evaluated using patient-reported responses to a follow-up survey regarding compliance with the prescribed alternate-day ferrous sulfate regimen. In the IV iron group, adherence was determined by reviewing infusion records to assess whether participants received the prescribed number of iron sucrose infusions based on their calculated iron deficit.

4 weeks
Adverse effects
Časové okno: 4 weeks

Medication-related adverse effects were assessed using a patient-reported survey. Participants were asked about symptoms or side effects experienced during treatment.

4 weeks
Blood loss
Časové okno: At the time of delivery until 5 days postpartum

Estimated maternal blood loss (mL) at the time of delivery, as documented in the medical record.

At the time of delivery until 5 days postpartum
. Mode of delivery
Časové okno: At the time of delivery

Mode of delivery, categorized as vaginal delivery or cesarean delivery, as documented in the medical record.

At the time of delivery
Apgar scores
Časové okno: At time of delivery, 1 and 5 minutes

Neonatal Apgar scores at 1 and 5 minutes after birth, as documented in the medical record. Range 0 to 10

At time of delivery, 1 and 5 minutes
NICU admission
Časové okno: At the time of delivery until 5 days postpartum

Admission to the neonatal intensive care unit (NICU) following delivery, recorded as yes or no.

At the time of delivery until 5 days postpartum
Neonatal hemoglobin
Časové okno: At the time of delivery until 5 days postpartum

Neonatal hemoglobin concentration (g/dL), as measured after birth and documented in the medical record.

At the time of delivery until 5 days postpartum

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. listopadu 2023

Primární dokončení (Aktuální)

12. září 2025

Dokončení studie (Aktuální)

30. října 2026

Termíny zápisu do studia

První předloženo

8. dubna 2024

První předloženo, které splnilo kritéria kontroly kvality

10. dubna 2024

První zveřejněno (Aktuální)

16. dubna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 23-55

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

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produkt vyrobený a vyvážený z USA

Ano

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