Clinical trial NCT03438227: Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Official title: Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia of Pregnancy
Iron Malabsorption
Keywords: Iron Deficiency Anemia of Pregnancy
oral iron supplementation
parenteral iron supplementation
maternal anemia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 Complete Blood Count 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.
Primary purpose: TREATMENT

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 United Kingdom 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 United States, 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 United Kingdom. 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 United States 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.

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

Primary outcomes:
measure: Maternal Anemia at Delivery
timeFrame: At delivery
Secondary outcomes:
measure: Maternal Hemoglobin at Delivery
timeFrame: On admission to inpatient obstetrics unit for delivery
measure: Number of Participants With Medication Adverse Events
timeFrame: 2 - 3 days after single intravenous iron infusion or initiation of oral iron
measure: Maternal Hemoglobin Below 10g/dl at Delivery
timeFrame: At delivery
measure: Maternal Ferritin at Delivery
timeFrame: At delivery
measure: Number of Participants Who Received Blood Transfusion
timeFrame: During inpatient admission for delivery of neonate
measure: Mode of Delivery
timeFrame: Once, at infant delivery
measure: Gestational Age at Delivery
timeFrame: Once, at infant delivery
measure: Birth Weight
timeFrame: Obtained once, at infant delivery
measure: Umbilical Cord Arterial pH
timeFrame: Drawn once from umbilical cord segment at delivery
measure: APGAR Scores at 1 Minutes of Life
timeFrame: Obtained at 1 minute of life
measure: Neonatal Hemoglobin
timeFrame: Drawn once from umbilical cord segment at birth
measure: Composite Neonatal Morbidity (Defined by the Occurrence of One or More of 10 Neonatal Morbidities.
timeFrame: At birth
measure: Neonatal Ferritin
timeFrame: Drawn once from umbilical cord segment at birth
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Saint Louis
country: United States
facility: Center for Outpatient Health, Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Indiana University
name: Method Tuuli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.