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

Primary Purpose

Iron Deficiency Anemia of Pregnancy, Iron Malabsorption

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Iron dextran
Ferrous sulfate 325mg
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy focused on measuring Iron Deficiency Anemia of Pregnancy, oral iron supplementation, parenteral iron supplementation, maternal anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Medicine
  • Center for Outpatient Health, Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravenous iron dextran infusion

Oral ferrous sulfate supplementation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant
Hemoglobin

Secondary Outcome Measures

Incidence of Medication Adverse events [Safety and Tolerability]
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
Hemoglobin
Maternal outcome: incidence of blood transfusion
Participant receiving transfusion of packed red blood cells during admission for delivery of infant obtained via medical chart review.
Maternal outcome: mode of delivery
Whether infant was delivered vaginally or via cesarean section
Neonatal outcomes: gestational age at delivery
Gestational age at delivery
Neonatal outcomes: birth weight
Infant birth weight
Neonatal outcomes: umblical cord gases
Umbilical cord gases
Neonatal outcomes: APGAR scores
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
Neonatal hemoglobin
Neonatal outcomes: neonatal morbidity composite
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

Full Information

First Posted
January 25, 2018
Last Updated
August 17, 2020
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03438227
Brief Title
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Acronym
IVIDA
Official Title
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy, Iron Malabsorption
Keywords
Iron Deficiency Anemia of Pregnancy, oral iron supplementation, parenteral iron supplementation, maternal anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous iron dextran infusion
Arm Type
Experimental
Arm Description
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
Arm Title
Oral ferrous sulfate supplementation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Iron dextran
Other Intervention Name(s)
Experimental
Intervention Description
Single intravenous infusion of iron dextran 1000mg.
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate 325mg
Other Intervention Name(s)
Active comparator
Intervention Description
Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Primary Outcome Measure Information:
Title
Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant
Description
Hemoglobin
Time Frame
On admission to inpatient obstetrics unit for delivery of infant
Secondary Outcome Measure Information:
Title
Incidence of Medication Adverse events [Safety and Tolerability]
Description
Research assistants will contact all patients receiving iron infusions 2 days after their infusion to assess for symptoms via a telephone questionnaire.
Time Frame
2 days after after iron infusion
Title
Maternal outcome: hemoglobin on postpartum day #1
Description
Hemoglobin
Time Frame
On day after participant delivered her infant (i.e. postpartum day #1)
Title
Maternal outcome: incidence of blood transfusion
Description
Participant receiving transfusion of packed red blood cells during admission for delivery of infant obtained via medical chart review.
Time Frame
During inpatient admission for delivery of neonate
Title
Maternal outcome: mode of delivery
Description
Whether infant was delivered vaginally or via cesarean section
Time Frame
Once, at infant delivery
Title
Neonatal outcomes: gestational age at delivery
Description
Gestational age at delivery
Time Frame
Once, at infant delivery
Title
Neonatal outcomes: birth weight
Description
Infant birth weight
Time Frame
Obtained once, at infant delivery
Title
Neonatal outcomes: umblical cord gases
Description
Umbilical cord gases
Time Frame
Drawn once from umbilical cord segment at birth
Title
Neonatal outcomes: APGAR scores
Description
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.
Time Frame
Obtained at 1 minute and 5 minutes of life
Title
Neonatal outcomes: neonatal hemoglobin
Description
Neonatal hemoglobin
Time Frame
Drawn once from umbilical cord segment at birth
Title
Neonatal outcomes: neonatal morbidity composite
Description
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
Time Frame
At birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be pregnant in order to participate
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Method Tuuli, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Center for Outpatient Health, Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18591330
Citation
American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 95: anemia in pregnancy. Obstet Gynecol. 2008 Jul;112(1):201-7. doi: 10.1097/AOG.0b013e3181809c0d. Erratum In: Obstet Gynecol. 2020 Jan;135(1):222.
Results Reference
background
PubMed Identifier
22512001
Citation
Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x. Erratum In: Br J Haematol. 2012 Aug;158(4):559.
Results Reference
background
PubMed Identifier
21975735
Citation
Reveiz L, Gyte GM, Cuervo LG, Casasbuenas A. Treatments for iron-deficiency anaemia in pregnancy. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD003094. doi: 10.1002/14651858.CD003094.pub3.
Results Reference
background
PubMed Identifier
34839481
Citation
Lewkowitz AK, Stout MJ, Cooke E, Deoni SC, D'Sa V, Rouse DJ, Carter EB, Tuuli MG. Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial. Am J Perinatol. 2022 Jun;39(8):808-815. doi: 10.1055/s-0041-1740003. Epub 2021 Nov 28.
Results Reference
derived

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

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