Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia, Anemia, Nephrology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/5/2018 |
| Start Date: | April 15, 2018 |
| End Date: | August 1, 2019 |
| Contact: | Adam K Lewkowitz, MD |
| Email: | lewkowitza@wustl.edu |
| Phone: | 314-362-7300 |
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.
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.
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.
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.
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
We found this trial at
1
site
4901 Forest Park Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Phone: 314-362-8523
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