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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia of Pregnancy Iron Malabsorption||Drug: Iron dextran Drug: Ferrous sulfate 325mg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
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
- 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
- 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.
- Maternal outcome: hemoglobin on postpartum day #1 [ Time Frame: On day after participant delivered her infant (i.e. postpartum day #1) ]Hemoglobin
- 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.
- Maternal outcome: mode of delivery [ Time Frame: Once, at infant delivery ]Whether infant was delivered vaginally or via cesarean section
- Neonatal outcomes: gestational age at delivery [ Time Frame: Once, at infant delivery ]Gestational age at delivery
- Neonatal outcomes: birth weight [ Time Frame: Obtained once, at infant delivery ]Infant birth weight
- Neonatal outcomes: umblical cord gases [ Time Frame: Drawn once from umbilical cord segment at birth ]Umbilical cord gases
- 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.
- Neonatal outcomes: neonatal hemoglobin [ Time Frame: Drawn once from umbilical cord segment at birth ]Neonatal hemoglobin
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438227
|Contact: Method Tuuli, MDemail@example.com|
|Contact: Heather Dickerson, RNfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University School of Medicine||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Heather A Dickerson, RN 317-944-7069 email@example.com|
|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|
|Principal Investigator:||Method Tuuli, MD||Indiana University|