Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial.

BACKGROUND: Iron-deficiency anemia in pregnancy is highly prevalent and presents significant risk to patients. Initial treatment is often with oral medication. We hypothesized that intravenous ferumoxytol would result in superior treatment of anemia as compared to oral ferrous sulfate. OBJECTIVE: This study aimed to investigate whether 2 infusions of intravenous ferumoxytol are superior to the use of twice-daily oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy. STUDY DESIGN: A randomized controlled trial was performed in which participants with anemic (hemoglobin <11 g/dL and hematocrit <33%) were allocated to receive either 2 infusions of 510 mg of intravenous ferumoxytol approximately 7 days apart, or 325 mg oral ferrous sulfate twice daily from enrollment to the end of their pregnancy. Participants were randomized in a 1:1 ratio to each treatment. Our primary outcome was the change in maternal hemoglobin. Secondary outcomes included maternal iron indices, maternal safety, and maternal tolerability. RESULTS: There were 124 participants (N=62 per group). In the intravenous iron group, the mean change in hemoglobin was 1.86 g/dL (95% confidence interval, 1.57 g/dL-2.14 g/dL) and in the oral group was 0.79 g/dL (95% confidence interval, 0.42 g/dL-1.17 g/dL) (P<.0001). The median change in ferritin between groups was 64.5 (range, 31-364) vs 8 (range, -436 to +167) (P=.0001). The median change in iron between groups was also statistically significant with 47.5 ug/dL (range, -133 ug/dL to +664 ug/dL) in the intravenous group vs 8.5 ug/dL (range, -313 ug/dL to +437 ug/dL) in the oral iron group (P=.001). CONCLUSION: Intravenous ferumoxytol was well tolerated, and it was associated with statistically significant increases in maternal hemoglobin, hematocrit, iron, and ferritin compared to oral ferrous sulfate.

Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate.

BACKGROUND: Anemia in pregnancy is common worldwide and has known maternal risks. The relationship between the types of treatment offered for maternal anemia and the effects on the fetus and newborn are largely uninvestigated. OBJECTIVE: This study aimed to investigate whether maternal treatment with intravenous ferumoxytol compared to oral ferrous sulfate results in an increase in neonatal hematologic and iron indices. These analyses were planned secondary outcomes and post hoc analysis from the trial with a primary outcome of change in maternal hemoglobin. STUDY DESIGN: A randomized controlled trial including 124 participants with anemia by World Health Organization criteria was performed in which participants were allocated in a 1:1 ratio to either 2 infusions of 510 mg of intravenous ferumoxytol or 325 mg oral ferrous sulfate twice daily. Fetal monitoring was performed during each intravenous iron infusion. Standard univariable statistical techniques were used to compare groups and to investigate associations between maternal and neonatal hemoglobin and iron indices. RESULTS: Cord blood hematological parameters were equivalent between groups. Hemoglobin was 15.7 g/dL vs 15.4 g/dL (P=.6) and hematocrit was 50.5% and 49.2% (P=.4) in those randomized to intravenous ferumoxytol and oral ferrous sulfate, respectively. Iron studies revealed higher cord blood ferritin concentrations in infants of participants treated with intravenous ferumoxytol (294 vs 186, P=.005). There were equivalent iron (158 vs 146, P=.4), transferrin (186 vs 196, P=.4) and total iron binding capacity (246 vs 244, P=1) in neonates of participants receiving intravenous vs oral treatment. There were no effects of the infusions observed on cardiotocography. Gestational age at birth was equivalent between groups. We noted a larger birthweight in neonates of participants treated with intravenous ferumoxytol (3215 g vs 3033 g, P=.09), which was not statistically significant. Post hoc analyses revealed a statistically significant correlation between neonatal ferritin and maternal hemoglobin (P=.006) and neonatal ferritin and maternal ferritin (P=.017) at admission for delivery. CONCLUSION: Neonates of participants who received intravenous ferumoxytol were born with higher ferritin concentrations in cord blood, at the same gestation with the same birthweight. Participants with higher hemoglobin and ferritin indices delivered infants with higher ferritin concentrations in cord blood.

Diversity Elements on Maternal Fetal Medicine (MFM) Fellowship Websites: Opportunity for Improvement in Recruitment and Representation.

Background: There has been a fundamental shift in recruitment of medical students and trainees into residency and fellowship programs during the Covid 19 pandemic.1 Historically, websites for medical trainees demonstrate a lack of explicit focus on diversity, equity, and inclusion. 2-7 Diversity has positive associations of improving healthcare team performance, patient care, and even financial goals.8 A lack of diversity may negatively impact patient care.9 Directed recruitment of underrepresented in medicine applicants has proven successful to increase diversity within training programs. Department websites have a more prominent role in virtual recruitment since the beginning of the COVID pandemic. Features on these websites may be utilized to attract underrepresented in medicine applicants and increase diversity in a field. Objective: To analyze Maternal Fetal Medicine fellowship websites for presence of diversity elements important to those people who are underrepresented in medicine. Study Design: Fellowship websites were accessed summer of 2021. They were analyzed for presence of twelve website elements that demonstrate commitment to diversity, including: 1) nondiscrimination statement; 2) diversity and inclusion message; 3) diversity specific language; 4) resources for trainees; 5) community demographics; 6-7) personalized biographies of faculty or fellows; 8-9) individual photographs of faculty or fellows; 10) photos or biographies of alumni; 11) diversity publications and; 12) department statistics. Program size, region, and location were collected. Self-reported underrepresented in medicine data on residency programs was extracted from the National Graduate Medical Education Survey from 2019. Programs were dichotomized into 6+ diversity elements. Nonparametric, chi-square and Fisher's exact were used for analysis. Results: Fellowship programs were analyzed (excluding military/fetal surgery, n = 91/94). Websites included a mean of 4.1± 2.5 diversity elements. Most featured fewer than 6 elements (n =75, 82.4%). When dichotomized to 6+ diversity elements, larger faculty size was the only significant factor (p=0.01). The majority of programs had fewer than 12 faculty members (n=54, 59.3%) and only 9.3% of those programs had 6 or more diversity elements. By contrast, among programs with more than 12 faculty, 29.7% had 6 or more diversity elements. Faculty photos, fellow photos, and diversity publications were the most commonly featured items (92.4%, 68.1%, and 49.5%, respectively). Mean rate of underrepresented in medicine was 18.8% ± 11.3% and no significant associations were noted. There was a non-significant difference in diversity elements in the West United States with a mean of 5.3±2.2 diversity elements, compared to 3.7±2 in the South. Conclusion: Fellowship websites convey information for trainees, especially in an era of virtual recruitment. This study highlights opportunities for directed improvements of websites for features which URIM medical trainees have identified as important.