title: Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Postpartum haemorrhage can lead to iron deficiency with and without anaemia, the clinical consequences of which include physical fatigue. Although oral iron is the standard treatment, it is often associated with gastrointestinal side effects and poor compliance. To date, no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage.
  
  
  METHODS
  In a single centre, open-labelled, randomised trial, women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care. Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health (Multidimensional Fatigue Inventory, Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire), at inclusion and at follow-up visits after three days, one week, three weeks, eight weeks, and 12 weeks postpartum. The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum, as measured by a subscale of the Multidimensional Fatigue Inventory. The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority, we set the minimal clinically relevant difference between the mean scores at 1.8, and the assumed standard deviation at 4.2. Hence, 87 participants per treatment group are needed in order to demonstrate superiority; to provide an extra margin for missing data and dropouts, 200 women will be included.
  
  
  CONCLUSIONS
  The study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage.
  
  
  BACKGROUND
  This trial is registered with Clinicaltrials.gov (identifier: NCT01895218) on 26 June 2013.
authors.affiliation: Department of Obstetrics, Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Kbh Ø Copenhagen, Denmark. charlotteholm@dadlnet.dk.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Holm
authors.forename: Lars Lykke
authors.initials: LL
authors.lastname: Thomsen
authors.forename: Astrid
authors.initials: A
authors.lastname: Norgaard
authors.forename: Jens
authors.initials: J
authors.lastname: Langhoff-Roos
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D002985:Clinical Protocols; D003718:Denmark; D004187:Disaccharides / Q000008:administration & dosage*; D005221:Fatigue / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008603:Mental Health; D006473:Postpartum Hemorrhage / Q000175:diagnosis; D011247:Pregnancy; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D018401:Sample Size; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004187:Disaccharides; D005290:Ferric Compounds; D006397:Hematinics; C557707:iron isomaltoside 1000