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.
| Condition or disease |
Intervention/treatment |
Phase |
Iron Deficiency Anemia of Pregnancy
Iron Malabsorption
|
Drug:
Ferrous sulfate 325mg
Other Names
Active comparator
|
Phase 4
|
Tracking Information
| First Submitted Date | January 25, 2018 |
| Last Update Posted Date | February 15, 2018 |
| Anticipated Start Date | March 01, 2018 |
| Anticipated Completion Date | August 01, 2019 |
| Anticipated Primary Completion Date | June 30, 2019 |
| Results First Submitted Date | N/A |
| Received Results Disposit Date | N/A |
Current Primary Outcome Measures
-
Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant
[Time Frame: On admission to inpatient obstetrics unit for delivery of infant]
Hemoglobin
Original Primary Outcome Measures
Not Available
Current Secondary Outcome Measures
-
Incidence of Medication Adverse events [Safety and Tolerability]
[Time Frame: 2 days after after iron infusion]
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
[Time Frame: On day after participant delivered her infant (i.e. postpartum day #1)]
Hemoglobin
-
Maternal outcome: incidence of blood transfusion
[Time Frame: During inpatient admission for delivery of neonate]
Participant receiving transfusion of packed red blood cells during admission for delivery of infant obtained via medical chart review.
-
Maternal outcome: mode of delivery
[Time Frame: Once, at infant delivery]
Whether infant was delivered vaginally or via cesarean section
-
Neonatal outcomes: gestational age at delivery
[Time Frame: Once, at infant delivery]
Gestational age at delivery
-
Neonatal outcomes: birth weight
[Time Frame: Obtained once, at infant delivery]
Infant birth weight
-
Neonatal outcomes: umblical cord gases
[Time Frame: Drawn once from umbilical cord segment at birth]
Umbilical cord gases
-
Neonatal outcomes: APGAR scores
[Time Frame: Obtained at 1 minute and 5 minutes of life]
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
[Time Frame: Drawn once from umbilical cord segment at birth]
Neonatal hemoglobin
-
Neonatal outcomes: neonatal morbidity composite
[Time Frame: At birth]
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
Original Secondary Outcome Measures
Not Available
Study Design
| Brief Title | 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 |
| 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.
|
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Estimated Enrollment | 120 |
| Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Double |
| Primary Purpose | Treatment |
| Conditions |
Iron Deficiency Anemia of Pregnancy
Iron Malabsorption
|
| Target Follow-Up Duration | N/A |
| Biospecimen: |
N/A
|
| Sampling Method | N/A |
| Study Population | N/A |
| Intervention |
Drug:
Iron dextran
Single intravenous infusion of iron dextran 1000mg.
Drug:
Ferrous sulfate 325mg
Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Other Names
Active comparator
|
| Study Groups/Cohorts |
Intravenous iron dextran infusion
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
Oral ferrous sulfate supplementation
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.
|
| Study Arms |
Experimental
Intravenous iron dextran infusion
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
Drug :
Iron dextran
Single intravenous infusion of iron dextran 1000mg.
Active Comparator
Oral ferrous sulfate supplementation
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.
Drug :
Ferrous sulfate 325mg
Oral iron supplementation with ferrous sulfate 325mg one to three times daily
|
| Arm |
Intervention/Treatment |
|
Experimental
Intravenous iron dextran infusion
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
|
Drug :
Iron dextran
Single intravenous infusion of iron dextran 1000mg.
|
|
Active Comparator
Oral ferrous sulfate supplementation
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.
|
Drug :
Ferrous sulfate 325mg
Oral iron supplementation with ferrous sulfate 325mg one to three times daily
|
Recruitment Information
| Recruitment Status: | Not yet recruiting |
| Enrollment | 120 |
| Completion Date | August 01, 2019 |
| 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
|
| Gender | Female |
| Age | N/A to N/A |
| Accepts Healthy Volunteers | No |
| Contacts |
|
| Listed Location Countries |
United States
|
Administrative Information
| NCT Number: | NCT03438227 |
| Other Study ID Numbers |
201712110
|
| Has Data Monitoring Committee | Yes |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
|
| IPD Sharing Statement |
Not Available
|
| Responsible Party | , |
| Study Sponsor |
|
| Collaborators |
Not Available
|
| Investigators |
Principal Investigator
Adam K Lewkowitz, MD
Washington University School of Medicine
|