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

Iron Deficiency Anemia of Pregnancy Clinical Trial

— IVIDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438227
• Other study ID #: 1809251633
• Status: Completed
• Phase: Phase 4
• Start date: April 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy
• Iron Malabsorption
• Malabsorption Syndromes

Intervention

Drug:
• Iron dextran
Single intravenous infusion of iron dextran 1000mg.
• Ferrous sulfate 325mg
Oral iron supplementation with ferrous sulfate 325mg one to three times daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. doi: 10.1111/j.1365-2141.2011.09012.x. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Anemia at Delivery	Number of participants with maternal hemoglobin <11g/dl at delivery	At delivery
Secondary	Maternal Hemoglobin at Delivery	Maternal hemoglobin on admission to inpatient obstetrics unit for delivery	On admission to inpatient obstetrics unit for delivery
Secondary	Number of Participants With Medication Adverse Events	Participants reporting symptoms when contacted by via telephone 2 - 3 days after their infusion of intravenous iron or initiation of oral iron	2 - 3 days after single intravenous iron infusion or initiation of oral iron
Secondary	Maternal Hemoglobin Below 10g/dl at Delivery	Number of participants with hemoglobin below 10g/dl at delivery	At delivery
Secondary	Maternal Ferritin at Delivery	Maternal serum ferritin level in µg/L at delivery	At delivery
Secondary	Number of Participants Who Received 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	Mode of Delivery	Whether infant was delivered vaginally or via cesarean section	Once, at infant delivery
Secondary	Gestational Age at Delivery	Gestational age in weeks at delivery	Once, at infant delivery
Secondary	Birth Weight	Neonatal weight at delivery	Obtained once, at infant delivery
Secondary	Umbilical Cord Arterial pH	Umbilical cord arterial pH obtained at delivery	Drawn once from umbilical cord segment at delivery
Secondary	APGAR Scores at 1 Minutes of Life	The APGAR score, named after the Virginia Apgar, pediatrician who came up with it, measures the physical condition of a newborn infant on a scale ranging from a minimum of 0 (worsts) to a maximum of 10 (best).	Obtained at 1 minute of life
Secondary	Neonatal Hemoglobin	Neonatal hemoglobin in g/dl at delivery	Drawn once from umbilical cord segment at birth
Secondary	Composite Neonatal Morbidity (Defined by the Occurrence of One or More of 10 Neonatal Morbidities.	Neonatal morbidity composite, defined by the occurrence of one or more of the following neonatal morbidities: neonatal seizures (diagnosed by clinician), intraventricular hemorrhage (diagnosed by clinician on brain MRI or Ultrasound), hypoxic-ischemic encephalopathy (diagnosed by clinician), neonatal hypothermic therapy (brain cooling as documented on inpatient record, sepsis (diagnosed by blood culture), respiratory distress syndrome (diagnosed by clinician), hyperbilirubinemia requiring photo therapy (diagnosed by clinician), birth injury (diagnosed by clinician), or meconium aspiration syndrome (diagnosed by clinician), neonatal intensive care unit admission (documented in the inpatient record).	At birth
Secondary	Neonatal Ferritin	Neonatal ferritin in ug/L at delivery	Drawn once from umbilical cord segment at birth