Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial

• Published in: BMJ open 2024-08, Vol.14 (8), p.e086553
• Main Authors: Afolabi, Bosede Bukola, Adaramoye, Victoria Olawunmi, Adeyemo, Titilope Adenike, Balogun, Mobolanle, Mitchell, Eleanor J, Walker, Kate, Akinajo, Opeyemi Rebecca, Abioye, Ibraheem Ajibola, Banke-Thomas, Aduragbemi, Babah, Ochuwa Adiketu, Chieme, Chisom Florence, Oshodi, Yewande, Quao, Rachel, Eboreime, Ejemai Amaize, Ogunsola, Folasade
• Format: Article
• Language: English
• Subjects: Administration, Intravenous; Administration, Oral; Adult; anaemia; Anemia; Anemia, Iron-Deficiency - drug therapy; Blood transfusions; depression & mood disorders; Drug dosages; Female; Ferric Compounds - administration & dosage; Ferric Compounds - therapeutic use; Ferrous Compounds - administration & dosage; Ferrous Compounds - therapeutic use; Hematinics - administration & dosage; Hematinics - therapeutic use; Hemoglobin; Humans; Infections; Intervention; Iron; Maltose - administration & dosage; Maltose - analogs & derivatives; Maltose - therapeutic use; Medical Management; Mental depression; Nigeria; Postpartum Period; postpartum women; Pregnancy; Protocol; Puerperal Disorders - drug therapy; quality of life; Randomized Controlled Trials as Topic; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-086553

IntroductionPostpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.ObjectiveTo determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria.Methods and analysisThis study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration