Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy
Khalafallah, AA and Dennis, AE and Ogden, K and Robertson, I and Charlton, RH and Bellette, JM and Shady, JL and Blesingk, N and Ball, M, Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy, BMJ Open, 2, (5) Article e000998. ISSN 2044-6055 (2012) [Refereed Article]
Background: To date, there are no data available concerning the impact of iron therapy on the long-term well-being and health-related quality of life (HRQoL) in pregnancy. Objective: To assess the long-term effect of iron therapy on HRQoL in pregnancy. Design: This is a follow-up study conducted between January 2010 and January 2011 of an earlier randomised open-label clinical trial of intravenous and oral iron versus oral iron for pregnancy-related iron deficiency anaemia. We used a modified version of the SF-36 questionnaire together with the original prospective HRQoL data collected during and after pregnancy. Participants and interventions: Of the original evaluable 183 pregnant Caucasian women randomised to receive oral iron or a single intravenous iron polymaltose infusion followed by oral iron maintenance, 126 women completed the follow-up HRQoL study. Methods: The participants were followed up 4 weeks after treatment, predelivery and postdelivery for a median period of 32 months (range, 26-42) with a wellbeing and HRQoL questionnaire using a modified SF-36 QoL-survey and child growth charts as set by the Australasian Paediatric Endocrine Group (APEG). Results: Patients who received intravenous iron demonstrated significantly higher haemoglobin and serum ferritin levels (p<0.001). There were strong associations between iron status and a number of the HRQoL parameters, with improved general health (p<0.001), improved vitality (physical energy) (p<0.001), less psychological downheartedness (p=0.005), less clinical depression (p=0.003) and overall improved mental health (p<0.001). The duration of breastfeeding was longer (p=0.046) in the intravenous iron group. The babies born in both groups recorded similarly on APEG growth chart assessments. Conclusions: Our data suggest that HRQoL is improved until after pregnancy in anaemic pregnant women by repletion of their iron stores during pregnancy. About 80% of the intravenous iron group showed a maintained normal ferritin until delivery with long-term benefits. Further studies to confirm these findings are warranted.