Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366698
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia
Sponsor:
Arrowhead Regional Medical Center
Organization:
Arrowhead Regional Medical Center
Study Overview
Official Title:
Randomized Control Trial Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDA
Brief 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
Detailed Description:
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 ngmL 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 patients consent they will be randomized 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 lemonorange 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 gdL 024 500 mg Our target Hgb will be 110 gdL
Patients will be given a symptom questionnaire at the time of enrollment to fill out We will analyze the patients 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 antepartumintrapartumpostpartum complications such as diabetes preeclampsiaeclampsia 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 Tukeys test or post hoc Student-Newman-Keuls tests A P 05 will be considered a statistically significant difference among groups
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 ngmL 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 patients consent they will be randomized 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 lemonorange 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 gdL 024 500 mg Our target Hgb will be 110 gdL
Patients will be given a symptom questionnaire at the time of enrollment to fill out We will analyze the patients 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 antepartumintrapartumpostpartum complications such as diabetes preeclampsiaeclampsia 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 Tukeys test or post hoc Student-Newman-Keuls tests A P 05 will be considered a statistically significant difference among groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None