Strengths and Limitations
The strengths of this study include the blinding of clinician, health
care team, patient, and statistician, the long follow-up period,
including longer-term assessment of child health. The findings can
reassure obstetric teams of the safety, efficacy, and comprehensive
benefits of IVI iron to treat ID and IDA in pregnancy.
The limitations include the variable number of participants who returned
for each post infusion appointment. This is particularly relevant for
the 4 weeks post infusion time point, where only around 50% of
participants in each arm attended. To address this, we conducted a
post-hoc sensitivity analysis assessing the number of participants
receiving an infusion as a function of the total number of participants
in each arm, assuming that patients who did not attend
an appointment did not require an
infusion. The results supported our non-equivalence findings. Although
our trial was conducted at a single site, we observed changes in all
blood markers of iron status over the study period biologically
consistent with a difference in the ability of both doses to adequately
restore iron status. This is important, given that even in this smaller
sample, the two-fold difference in the need for a repeat infusion
between the doses represents a significant addition to standard care,
with associated costs and no differences in neonatal or child outcome.