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Żelazo dożylne w porównaniu z żelazem doustnym w leczeniu niedokrwistości z niedoboru żelaza (IDA)

4 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

518

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • California
      • Colton, California, Stany Zjednoczone, 92324
        • Arrowhead Regional Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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

Inne nazwy:
  • Sacharoza żelaza
Komparator placebo: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Hemoglobin difference
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Preterm delivery
Ramy czasowe: At the time of delivery

Comparing hemoglobin levels to gestational age at delivery

At the time of delivery
Depression
Ramy czasowe: 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
Ramy czasowe: At time of delivery

Comparing birthweight to hemoglobin levels at time of admission

At time of delivery
Pre-delivery Hemoglobin
Ramy czasowe: Obtained at time of delivery

Comparing pre-delivery hemoglobin levels

Obtained at time of delivery
Symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 4 weeks

Comparing the number of patients with Hgb < 10.5 after intervention

4 weeks
Treatment adherence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

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Sponsor

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 listopada 2023

Zakończenie podstawowe (Rzeczywisty)

12 września 2025

Ukończenie studiów (Rzeczywisty)

30 października 2026

Daty rejestracji na studia

Pierwszy przesłany

8 kwietnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 kwietnia 2024

Pierwszy wysłany (Rzeczywisty)

16 kwietnia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 23-55

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .