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.

Comparison of patient attitudes and provider perceptions regarding medical student involvement in obstetric/gynecologic care.

BACKGROUND: Community physicians are becoming increasingly involved in clinical medical education. Some obstetrician/gynecologists have expressed reluctance to participate as clinical preceptors for medical students due to the sensitive nature of many of their patient encounters and concern for diminished patient satisfaction. PURPOSES: The purpose was to evaluate the willingness of community ob/gyn patients to participate in clinical medical education and to determine the accuracy of provider perceptions regarding this issue. METHODS: Surveys were distributed to women seeking ob/gyn care at 4 private practice sites in Tucson, Arizona. The surveys explored patient attitudes toward community physician involvement in clinical medical education as well as factors influencing personal willingness to include students as part of their healthcare team. Similar surveys were administered to the ob/gyn providers in those sites and evaluated their expectations of aggregate patient responses. RESULTS: Of 234 patient respondents, 87.6% believed that physicians have a responsibility to participate in medical education. Providers underestimated the number of patients for whom such participation would positively influence their personal provider choice (12.7% vs. 30.8%, p<.01) and overestimated negative (16.7% vs. 6.8%, p<.01) influence. Providers also underestimated acceptance rates of student pelvic examinations based on learner gender (13.8% vs. 24.3% male students, p=.01; 28.1% vs. 44.4% female students, p<.01). CONCLUSIONS: Patients in southern Arizona recognize and appreciate physicians' responsibility to educate future providers of women's healthcare. Providers may underestimate patient acceptance and value of students as part of their healthcare team. This bias may unnecessarily limit student exposure to clinical learning opportunities.