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

Trials

Volumn 16, Issue 1, 2015, Pages

  Holm, Charlotte ^a,b   Thomsen, Lykke ^b   Norgaard, Astrid ^a   Langhoff Roos, Jens ^a  

^a International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health   (Denmark)

^b Pharmacosmos AS   (Denmark)

Author keywords

Intravenous iron; Iron deficiency; Postpartum fatigue; Postpartum haemorrhage

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CALCIUM; CREATININE; FERRITIN; HEMOGLOBIN; IRON; IRON DERIVATIVE; IRON ISOMALTOSIDE 1000; PHOSPHATE; POTASSIUM; SODIUM; TRANSFERRIN; UNCLASSIFIED DRUG; UREA; ANTIANEMIC AGENT; DISACCHARIDE; FERRIC ION;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALBUMIN BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CALCIUM BLOOD LEVEL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DISEASE ASSESSMENT; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; EDINBURGH POSTNATAL DEPRESSION SCALE; ERYTHROCYTE TRANSFUSION; FATIGUE; FEMALE; FERRITIN BLOOD LEVEL; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GENERAL HEALTH STATUS ASSESSMENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; INTERVENTION STUDY; IRON THERAPY; MAJOR CLINICAL STUDY; MEDICAL CARE; MENTAL HEALTH; MULTIDIMENSIONAL FATIGUE INVENTORY; OPEN STUDY; OUTCOME ASSESSMENT; PHOSPHATE BLOOD LEVEL; POSTPARTUM HEMORRHAGE; POSTPARTUM QUESTIONNAIRE; POTASSIUM BLOOD LEVEL; PUERPERIUM; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SODIUM BLOOD LEVEL; STANDARD; STRUCTURED QUESTIONNAIRE; TRANSFERRIN BLOOD LEVEL; TREATMENT DURATION; UREA BLOOD LEVEL; ANEMIA, IRON-DEFICIENCY; BLOOD; CLINICAL PROTOCOL; DENMARK; INTRAVENOUS DRUG ADMINISTRATION; METHODOLOGY; PREGNANCY; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; QUESTIONNAIRE; SAMPLE SIZE; TIME; TREATMENT OUTCOME;

ANEMIA, IRON-DEFICIENCY; CLINICAL PROTOCOLS; DENMARK; DISACCHARIDES; FATIGUE; FEMALE; FERRIC COMPOUNDS; HEMATINICS; HUMANS; INFUSIONS, INTRAVENOUS; MENTAL HEALTH; POSTPARTUM HEMORRHAGE; PREGNANCY; PSYCHIATRIC STATUS RATING SCALES; RESEARCH DESIGN; SAMPLE SIZE; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84924296113     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-16-5     Document Type: Article

References (42)

1. Gyte G: The Significance of blood loss at delivery. MIDIRS Midwifery Digest 1992, 2:88-92.
2. Ripley DL: Uterine emergencies. Atony, inversion, and rupture. Obstet Gynecol Clin N Am 1999, 26:419-34. 10.1016/S0889-8545(05)70087-5
3. WHO: WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization Press; 2012.
4. Koury MJ, Ponka P: New insights into erythropoiesis: the roles of folate, vitamin B, and iron*. Annu Rev Nutr 2004, 24:105-31. 10.1146/annurev.nutr.24.012003.132306
5. Lee KA, Zaffke ME: Longitudinal changes in fatigue and energy during pregnancy and the postpartum period. J Obstetric Gynecol Neonatal Nursing 1999, 28:183-91. 10.1111/j.1552-6909.1999.tb01983.x
6. Dewey KG, Nommsen-Rivers LA, Heinig MJ, Cohen RJ: Risk factors for suboptimal infant breastfeeding behavior, delayed onset of lactation, and excess neonatal weight loss. Pediatrics 2003, 112:607-19. 10.1542/peds.112.3.607
7. Chapman DJ, Pérez-Escamilla R: Does delayed perception of the onset of lactation shorten breastfeeding duration? J Hum Lact 1999, 15:107-11. 10.1177/089033449901500207
8. Rioux FM, Savoie N, Allard J: Is there a link between postpartum anemia and discontinuation of breastfeeding? Can J Diet Pract Res 2006, 67:72-6. 10.3148/67.2.2006.72
9. Bodnar LM, Cogswell ME, McDonald T: Have we forgotten the significance of postpartum iron deficiency? Am J Obstet Gynecol 2005, 193:36-44. 10.1016/j.ajog.2004.12.009
10. Geisser P, Baer M, Schaub E: Structure/histotoxicity relationship of parenteral iron preparations. Arzneimittelforschung 1992, 42:1439-52.
11. Lyseng-Williamson KA, Keating GM: Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. Drugs 2009, 69:739-56. 10.2165/00003495-200969060-00007
12. European Medicines Agency: Assessments Report for: Iron Containing Intravenous (IV) Medicinal Products. London: European Medicines Agency; 2013.
13. Jahn MR, Andreasen HB, Fütterer S, Nawroth T, Schünemann V, Kolb U, et al.: A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm 2011, 78:480-91. 10.1016/j.ejpb.2011.03.016
14. Hildebrandt PR, Bruun NE, Nielsen OW, Pantev E, Shiva F, Videbæk L, et al.: Effects of administration of iron isomaltoside 1000 in patients with chronic heart failure. A pilot study. Transfusion Altern Transfusion Med 2010, 11:131-7. 10.1111/j.1778-428X.2010.01145.x
15. Wikström B, Bhandari S, Barany P, Kalra PA, Ladefoged S, Wilske J, et al.: Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease. J Nephrol 2011, 24:589-96. 10.5301/JN.2011.6248
16. Nordfjeld K, Andreasen H, Thomsen LL: Pharmacokinetics of iron isomaltoside 1000 in patients with inflammatory bowel disease. Drug Design Dev Therapy 2012, 6:43-51.
17. Reinisch W, Staun M, Tandon RK, Altorjay I, Thillainayagam AV, Gratzer C, et al.: A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED). Am J Gastroenterol 2013, 108:1877-88. 10.1038/ajg.2013.335
18. Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C: UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol 2012, 156:588-600. 10.1111/j.1365-2141.2011.09012.x
19. Breymann C, Bian X, Blanco-Capito LR, Chong C, Mahmud G, Rehman R: Expert recommendations for the diagnosis and treatment of iron-deficiency anemia during pregnancy and the postpartum period in the Asia-Pacific region. J Perinat Med 2011, 39:113-21.
20. Breymann C, Hovegger C, Holzgreve W, Surbek D: Diagnosis and treatment of iron-deficiency anaemia during pregnancy and postpartum. Arch Gynecol Obstet 2010, 282:577-80. 10.1007/s00404-010-1532-z
21. Kiss H, Konnaris C: Eisenmangelanämie in der Schwangerschaft und postpartum. Österreichische Gesellschaft Gynäkologie Geburtshilfe 2011. [in German] [http://www.oeggg.at/fileadmin/user_upload/downloads/Leitlinien/2011_16_03_11_LL_Anaemie_Schwangerschaft_final_1011.pdf ]
22. Merino SG, Picado AL, Hernández HM, Mesa JM, Lasa IL, Barandiarán FA: Ensayo clínico aleatorizado para evaluar la efectividad de dos vías de administración de hierro, oral e intravenosa, en el tratamiento de la anemia ferropénica posparto. Clínica Investigación Ginecol Obstetricia 2012, 39:190-5. [in Spanish]
23. Westad S, Backe B, Salvesen KÅ, Nakling J, Økland I, Borthen I, et al.: A 12-week randomised study comparing intravenous iron sucrose versus oral ferrous sulphate for treatment of postpartum anemia. Acta Obstet Gynecol Scand 2008, 87:916-23. 10.1080/00016340802317802
24. Bhandal N, Russell R: Intravenous versus oral iron therapy for postpartum anaemia. BJOG Int J Obstetrics Gynaecol 2006, 113:1248-52. 10.1111/j.1471-0528.2006.01062.x
25. van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A: Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol 2007, 110:267-78. 10.1097/01.AOG.0000275286.03283.18
26. Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R: Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008, 199:435. e1-7
27. Breymann C, Gliga F, Bejenariu C, Strizhova N: Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Int J Gynecol Obstet 2008, 101:67-73. 10.1016/j.ijgo.2007.10.009
28. Verma S, Inamdar S, Malhotra N: Intravenous iron therapy versus oral iron in postpartum patients in rural area. J South Asian Federation Obstetrics Gynaecol 2011, 3:67-70.
29. Froessler B, Cocchiaro C, Saadat-Gilani K, Hodyl N, Dekker G: Intravenous iron sucrose versus oral iron ferrous sulfate for antenatal and postpartum iron deficiency anemia: a randomized trial. J Matern Fetal Neonatal Med 2013, 26:654-9. 10.3109/14767058.2012.746299
30. Jain G, Palaria U, Jha SK: Intravenous iron in postpartum anemia. J Obstetrics Gynecol India 2013, 63:45-8. 10.1007/s13224-012-0240-y
31. Mumtaz A, Farooq F: Comparison for Effects of Intravenous versus Oral Iron Therapy for Postpartum Anemia. 2014. http://pjmhsonline.com/comparison_for_effects_of_intrav.htm
32. Milman N: Postpartum anemia I: definition, prevalence, causes, and consequences. Ann Hematol 2011, 90:1247-53. 10.1007/s00277-011-1279-z
33. Dodd JM, Dare MR, Middleton P: Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev 2004, CD004222.
34. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice E6 (R1). London: European Medicines Agency; 2002.
35. National Board of Health: Healthy Habits - Before, During and After Pregnancy 2010. http://sundhedsstyrelsen.dk/publ/Publ2010/CFF/English/SundeVaner_en.pdf
36. Crichton RR, Wilmet S, Legssyer R, Ward RJ: Molecular and cellular mechanisms of iron homeostasis and toxicity in mammalian cells. J Inorg Biochem 2002, 91:9-18. 10.1016/S0162-0134(02)00461-0
37. Smets EM, Garssen B, Bonke B, de Haes JC: The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995, 39:315-25. 10.1016/0022-3999(94)00125-O
38. Cox JL, Holden JM, Sagovsky R: Detection of postnatal depression. Development of the 10-item Edinburgh postnatal depression scale. Br J Psychiatry 1987, 150:782-6. 10.1192/bjp.150.6.782
39. Jansen AJG, Essink-Bot M, Beckers EAM, Hop WCJ, Schipperus MR, van Rhenen DJ: Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes. Br J Haematol 2003, 121:270-4. 10.1046/j.1365-2141.2003.04272.x
40. Jansen AJG, Essink-Bot M, Duvekot JJ, van Rhenen DJ: Psychometric evaluation of health-related quality of life measures in women after different types of delivery. J Psychosom Res 2007, 63:275-81. 10.1016/j.jpsychores.2007.06.003
41. Gibson J, McKenzie-McHarg K, Shakespeare J, Price J, Gray R: A systematic review of studies validating the Edinburgh postnatal depression scale in antepartum and postpartum women. Acta Psychiatr Scand 2009, 119:350-64. 10.1111/j.1600-0447.2009.01363.x
42. Prick BW, Steegers EA, Jansen AG, Hop WC, Essink-Bot M, Peters NC, et al.: Well being of obstetric patients on minimal blood transfusions (WOMB trial). BMC Pregnancy Childbirth 2010, 10:83. 10.1186/1471-2393-10-83