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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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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<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.</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 & 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. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</rights><rights>2012 2012, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2012, Published by the BMJ Publishing Group Limited. 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. 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<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.</description><subject>Anemia</subject><subject>Birth weight</subject><subject>Breastfeeding & lactation</subject><subject>Clinical trials</subject><subject>Hemoglobin</subject><subject>Iron</subject><subject>Patients</subject><subject>Postpartum depression</subject><subject>Pregnancy</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Reproductive Medicine, Obstetrics and Gynaecology</subject><subject>White people</subject><subject>Womens health</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>PIMPY</sourceid><recordid>eNqNkU1LJDEQhoPsouL6CxYk4GUv7eazPy6CiLqCsBf3HNI9Fc2QTtpkepb599Yws6J78pIK1FMv9dZLyHfOLjiX9c9-XKYJYiUYFxVjrOvaA3IsmFJVzbT-8u5_RE5LWSLDlO60FofkSEjWNozzYxIenzNAtQGbqUshpL_VPNHkqKXZxkUafYEFHYKPfrCBrrLHF9s-rrJdQ0xzoWvIBUvK2PI5RRTK1EYLo7cI0inDU7Rx2HwjX50NBU739YT8ub15vP5VPfy-u7--eqh61YhVxVkN7dBB3TnumrbpXL-oO9kMTEgAy5Wz0inZt8op6Bsn0L1UjElXS657IU_I5U53mvsRFgNslw1myn60eWOS9eZjJ_pn85TWRqq2bZREgR97gZxeZigrg3cYIAQbAR0bzrnC-2mhED3_D12mOUe0Z3jTSq05YzVSckcNOZWSwb0tw5nZBmr2gZptoGYXKE6dvffxNvMvPgQudgBOf0rxFYKarZo</recordid><startdate>2012</startdate><enddate>2012</enddate><creator>Khalafallah, Alhossain A</creator><creator>Dennis, Amanda E</creator><creator>Ogden, Kath</creator><creator>Robertson, Iain</creator><creator>Charlton, Ruth H</creator><creator>Bellette, Jackie M</creator><creator>Shady, Jessica L</creator><creator>Blesingk, Nep</creator><creator>Ball, Madeleine</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>2012</creationdate><title>Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy</title><author>Khalafallah, Alhossain A ; Dennis, Amanda E ; Ogden, Kath ; Robertson, Iain ; Charlton, Ruth H ; Bellette, Jackie M ; Shady, Jessica L ; Blesingk, Nep ; Ball, Madeleine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-106e8c9e69f1f7879fbd6937c023eea14fa3f43b84f4eb7f209934003f6315b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Anemia</topic><topic>Birth weight</topic><topic>Breastfeeding & lactation</topic><topic>Clinical trials</topic><topic>Hemoglobin</topic><topic>Iron</topic><topic>Patients</topic><topic>Postpartum depression</topic><topic>Pregnancy</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Reproductive Medicine, Obstetrics and Gynaecology</topic><topic>White people</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Khalafallah, Alhossain A</au><au>Dennis, Amanda E</au><au>Ogden, Kath</au><au>Robertson, Iain</au><au>Charlton, Ruth H</au><au>Bellette, Jackie M</au><au>Shady, Jessica L</au><au>Blesingk, Nep</au><au>Ball, Madeleine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2012</date><risdate>2012</risdate><volume>2</volume><issue>5</issue><spage>e000998</spage><pages>e000998-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>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<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.</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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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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