Phase 4
N=38
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial
Iron Deficiency Anemia of Pregnancy · Iron Malabsorption
Bottom Line
View on ClinicalTrials.gov: NCT03438227 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Maternal Anemia at Delivery — 4; 11 Participants — p=0.039
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Iron dextran (Drug); Ferrous sulfate 325mg (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Anemia at Delivery |
4; 11 | 0.039 sig |
| SECONDARY Maternal Hemoglobin at Delivery |
11.0; 9.9 | 0.019 sig |
| SECONDARY Number of Participants With Medication Adverse Events |
0; 0; 3; 3 | 0.029 sig |
| SECONDARY Maternal Hemoglobin Below 10g/dl at Delivery |
1; 7 | 0.029 sig |
| SECONDARY Maternal Ferritin at Delivery |
129.8; 26.6 | 0.19 |
| SECONDARY Number of Participants Who Received Blood Transfusion |
0; 2 | 0.194 |
| SECONDARY Mode of Delivery |
4; 8; 6; 5 | 0.414 |
| SECONDARY Gestational Age at Delivery |
38.1; 36.9 | 0.15 |
| SECONDARY Birth Weight |
3174.0; 3029.2 | 0.571 |
| SECONDARY Umbilical Cord Arterial pH |
7.24; 7.29 | 0.12 |
| SECONDARY APGAR Scores at 1 Minutes of Life |
8; 8 | 0.049 sig |
| SECONDARY Neonatal Hemoglobin |
13.4; 13.5 | 0.933 |
| SECONDARY Composite Neonatal Morbidity (Defined by the Occurrence of One or More of 10 Neonatal Morbidities. |
2; 4 | 0.66 |
| SECONDARY Neonatal Ferritin |
169.4; 147.1 | 0.633 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03438227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.