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Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial (IVIDA)

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ClinicalTrials.gov Identifier: NCT03438227
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Method Tuuli, Indiana University

Brief Summary:
Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. While treatment of iron-deficiency anemia with iron supplementation is recommended, treatment strategies remain controversial: the American College of Obstetrics and Gynecology recommends oral iron supplementation with parental iron reserved for the rare patient who cannot tolerate or will not take oral iron, while UK professional organizations recommend a more liberal use of parenteral iron. The reason for these disparate recommendations is that few high-quality studies comparing oral to parenteral iron have been conducted in developed countries, and the potential impact of parental iron treatment on obstetric and perinatal outcomes remains unclear. We propose the first randomized-controlled trial in the United States describing the effectiveness and safety of treating pregnant women with iron-deficiency anemia with a protocol including parenteral iron compared with a protocol based on oral iron.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia of Pregnancy Iron Malabsorption Drug: Iron dextran Drug: Ferrous sulfate 325mg Phase 4

Detailed Description:

Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe, can have serious consequences for mothers and babies. In the U.S., anemia affects nearly 20% of pregnancies and the majority is iron-deficiency anemia. Therefore, treatment of iron-deficiency anemia with iron supplementation is recommended.1 However, there is controversy about the treatment strategies.

The American College of Obstetrics and Gynecology recommends oral iron supplementation for iron-deficiency anemia in pregnancy, with parental iron reserved only for the "rare patient who cannot tolerate or will not take oral iron" (1) Conversely, guidelines from the U.K. are more liberal on the use of parental iron for the treatment of iron-deficiency anemia in pregnancy (2). Both treatment guidelines are based on limited data regarding the risks and benefits of parental iron for treatment of iron-deficiency anemia in pregnancy. The majority of randomized trials were conducted in developing country settings. In fact, few high-quality studies have been conducted in developed countries, and none has been conducted in the U.S. Moreover, there is limited data from prior studies on the impact of parental iron treatment on perinatal outcomes. The most recent Cochrane review including mostly from trials conducted in low-income countries found that, although parenteral iron improved hemoglobin levels and iron stores than the oral route, no clinical outcomes were assessed and there were insufficient data on adverse effects (3). The authors concluded that "large, good quality trials, assessing clinical outcomes including adverse effects … are required" (3).

This randomized controlled trial aims to assess the effectiveness and safety of treating pregnant women with iron-deficiency anemia with a protocol including parenteral iron compared with a protocol based on oral iron. We hypothesize that treating iron-deficiency anemia with parental iron is associated with improved maternal and neonatal outcomes compared with a protocol based on oral iron. To increase generalizability of the findings, we will use broad inclusion criteria and analyze data using the intention-to-treat principle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants at less than 28 weeks gestation will have an anemia evaluation and work up per standard prenatal care. Those who meet a clinical diagnosis of iron-deficiency anemia will initiate oral iron and have their CBC rechecked between 24 and 28 weeks gestation. If their hemoglobin is less than 10 mg/dL, they will be randomized to either continue their oral iron supplementation or receive a single intravenous dextran iron transfusion. If the patient is enrolled after 28 weeks and receives a diagnosis of iron deficiency anemia, she will be randomized at that time.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The research team will be blinded to the patients' treatment arm. A team of resident physicians who are unfamiliar with the study aims will provide standard obstetric care to all participants.
Primary Purpose: Treatment
Official Title: Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Intravenous iron dextran infusion
Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor & Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion
Drug: Iron dextran
Single intravenous infusion of iron dextran 1000mg.
Other Name: Experimental

Active Comparator: Oral ferrous sulfate supplementation
Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider.
Drug: Ferrous sulfate 325mg
Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Other Name: Active comparator




Primary Outcome Measures :
  1. Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant [ Time Frame: On admission to inpatient obstetrics unit for delivery of infant ]
    Hemoglobin


Secondary Outcome Measures :
  1. Incidence of Medication Adverse events [Safety and Tolerability] [ Time Frame: 2 days after after iron infusion ]
    Research assistants will contact all patients receiving iron infusions 2 days after their infusion to assess for symptoms via a telephone questionnaire.

  2. Maternal outcome: hemoglobin on postpartum day #1 [ Time Frame: On day after participant delivered her infant (i.e. postpartum day #1) ]
    Hemoglobin

  3. Maternal outcome: incidence of blood transfusion [ Time Frame: During inpatient admission for delivery of neonate ]
    Participant receiving transfusion of packed red blood cells during admission for delivery of infant obtained via medical chart review.

  4. Maternal outcome: mode of delivery [ Time Frame: Once, at infant delivery ]
    Whether infant was delivered vaginally or via cesarean section

  5. Neonatal outcomes: gestational age at delivery [ Time Frame: Once, at infant delivery ]
    Gestational age at delivery

  6. Neonatal outcomes: birth weight [ Time Frame: Obtained once, at infant delivery ]
    Infant birth weight

  7. Neonatal outcomes: umblical cord gases [ Time Frame: Drawn once from umbilical cord segment at birth ]
    Umbilical cord gases

  8. Neonatal outcomes: APGAR scores [ Time Frame: Obtained at 1 minute and 5 minutes of life ]
    APGAR scores. The APGAR score measures the physical condition of a newborn infant on a scale from 0 to 10 by adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin color.

  9. Neonatal outcomes: neonatal hemoglobin [ Time Frame: Drawn once from umbilical cord segment at birth ]
    Neonatal hemoglobin

  10. Neonatal outcomes: neonatal morbidity composite [ Time Frame: At birth ]
    Neonatal morbidity composite, defined by the occurrence of one or more of the following neonatal morbidities: neonatal seizures, intraventricular hemorrhage, hypoxic-ischemic encephalopathy, neonatal hypothermic therapy, sepsis, respiratory distress syndrome, hyperbilirubinemia requiring photo therapy, birth injury, or meconium aspiration syndrome, NICU admission



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients must be pregnant in order to participate
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Iron-deficiency anemia (serum ferritin <30 micrograms, normal hemoglobin electrophoresis, and hemoglobin <10 mg/dL), planned delivery at Barnes-Jewish Hospital

Exclusion Criteria:

  • Non-iron-deficiency anemia, multiple gestation, prenatally diagnosed major fetal anomalies, known aneuploidy, planned delivery at other hospital, inability to obtain consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438227


Contacts
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Contact: Method Tuuli, MD 317-944-8182 mtulli@iu.edu
Contact: Heather Dickerson, RN 317-944-7069 hratclif@iu.edu

Locations
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United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Heather A Dickerson, RN    317-944-7069    hratclif@iu.edu   
Principal Investigator: Methodius G Tuuli, MD, MPH         
United States, Missouri
Center for Outpatient Health, Washington University in St. Louis Completed
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Method Tuuli, MD Indiana University
Publications:
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Responsible Party: Method Tuuli, Professor of Obstetrics and Gynecology, Indiana University
ClinicalTrials.gov Identifier: NCT03438227    
Other Study ID Numbers: 1809251633
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Method Tuuli, Indiana University:
Iron Deficiency Anemia of Pregnancy
oral iron supplementation
parenteral iron supplementation
maternal anemia
Additional relevant MeSH terms:
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Malabsorption Syndromes
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Dextrans
Iron-Dextran Complex
Anticoagulants
Plasma Substitutes
Blood Substitutes
Hematinics