Mode
Text Size
Log in / Sign up
Phase 4 N=38 Randomized Double-blind Treatment

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

Iron Deficiency Anemia of Pregnancy · Iron Malabsorption

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search