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Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy

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 betwee...

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Published in:BMJ open 2012, Vol.2 (5), p.e000998
Main Authors: Khalafallah, Alhossain A, Dennis, Amanda E, Ogden, Kath, Robertson, Iain, Charlton, Ruth H, Bellette, Jackie M, Shady, Jessica L, Blesingk, Nep, Ball, Madeleine
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description 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 well-being 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
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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 well-being 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&lt;0.001). There were strong associations between iron status and a number of the HRQoL parameters, with improved general health (p&lt;0.001), improved vitality (physical energy) (p&lt;0.001), less psychological downheartedness (p=0.005), less clinical depression (p=0.003) and overall improved mental health (p&lt;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.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2012-000998</identifier><identifier>PMID: 23087011</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Anemia ; Birth weight ; Breastfeeding &amp; lactation ; Clinical trials ; Hemoglobin ; Iron ; Patients ; Postpartum depression ; Pregnancy ; Quality of life ; Questionnaires ; Reproductive Medicine, Obstetrics and Gynaecology ; White people ; Womens health</subject><ispartof>BMJ open, 2012, Vol.2 (5), p.e000998</ispartof><rights>2012, Published by the BMJ Publishing Group Limited. 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For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-106e8c9e69f1f7879fbd6937c023eea14fa3f43b84f4eb7f209934003f6315b23</citedby><cites>FETCH-LOGICAL-b472t-106e8c9e69f1f7879fbd6937c023eea14fa3f43b84f4eb7f209934003f6315b23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1783551006/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1783551006?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>112,113,230,314,723,776,780,881,3181,4010,25731,27526,27527,27900,27901,27902,36989,36990,44566,53766,53768,74869,77336,77337,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23087011$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Khalafallah, Alhossain A</creatorcontrib><creatorcontrib>Dennis, Amanda E</creatorcontrib><creatorcontrib>Ogden, Kath</creatorcontrib><creatorcontrib>Robertson, Iain</creatorcontrib><creatorcontrib>Charlton, Ruth H</creatorcontrib><creatorcontrib>Bellette, Jackie M</creatorcontrib><creatorcontrib>Shady, Jessica L</creatorcontrib><creatorcontrib>Blesingk, Nep</creatorcontrib><creatorcontrib>Ball, Madeleine</creatorcontrib><title>Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>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. 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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. 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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 well-being 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&lt;0.001). There were strong associations between iron status and a number of the HRQoL parameters, with improved general health (p&lt;0.001), improved vitality (physical energy) (p&lt;0.001), less psychological downheartedness (p=0.005), less clinical depression (p=0.003) and overall improved mental health (p&lt;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.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>23087011</pmid><doi>10.1136/bmjopen-2012-000998</doi><oa>free_for_read</oa></addata></record>
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source BMJ Open Access Journals; Publicly Available Content Database; BMJ Journals; PubMed Central
subjects Anemia
Birth weight
Breastfeeding & lactation
Clinical trials
Hemoglobin
Iron
Patients
Postpartum depression
Pregnancy
Quality of life
Questionnaires
Reproductive Medicine, Obstetrics and Gynaecology
White people
Womens health
title Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy
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