Iron Deficiency Anemia of Pregnancy Clinical Trial
— IVIDAOfficial title:
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Verified date | August 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | Center for Outpatient Health, Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
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. — View 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. Erratum in: Br J Haematol. 2012 Aug;158(4):559. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant | Hemoglobin | On admission to inpatient obstetrics unit for delivery of infant | |
Secondary | 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. | 2 days after after iron infusion | |
Secondary | Maternal outcome: hemoglobin on postpartum day #1 | Hemoglobin | On day after participant delivered her infant (i.e. postpartum day #1) | |
Secondary | 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. | During inpatient admission for delivery of neonate | |
Secondary | Maternal outcome: mode of delivery | Whether infant was delivered vaginally or via cesarean section | Once, at infant delivery | |
Secondary | Neonatal outcomes: gestational age at delivery | Gestational age at delivery | Once, at infant delivery | |
Secondary | Neonatal outcomes: birth weight | Infant birth weight | Obtained once, at infant delivery | |
Secondary | Neonatal outcomes: umblical cord gases | Umbilical cord gases | Drawn once from umbilical cord segment at birth | |
Secondary | 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. | Obtained at 1 minute and 5 minutes of life | |
Secondary | Neonatal outcomes: neonatal hemoglobin | Neonatal hemoglobin | Drawn once from umbilical cord segment at birth | |
Secondary | 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 | At birth |
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