Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anemia in Nigerian women (IVON-PP): an open label randomized controlled trial alongside an implementation study. Increases risk of maternal complications such as infection, poor wound healing, fatigue, and depression and increase the risk of maternal death

1. Overview of IVON-PP
Professor Bosede B. Afolabi (MBChB, DM(Notts), FRCOG, FWACS,
FMCOG)
Principal Investigator, IVON-PP
Faculty of Clinical Sciences, College of Medicine, University of
Lagos/
Lagos University Teaching Hospital (LUTH)

2. What is IVON-PP?
• Intravenous ferric carboxymaltose versus oral
ferrous sulphate for the treatment of moderate
to severe postpartum anemia in Nigerian women
(IVON-PP): an open label randomized controlled
trial alongside an implementation study
• Hybrid – RCT and IS
• A 3-year project
2

3. Anaemia during pregnancy and
postpartum
• Commonest medical condition that may complicate
pregnancy
• Defined by WHO as Hb conc <11g/dl
• Postpartum period caused by PPH, infections, worm
infestations, micronutrient deficiencies, & pre-
existing anaemia in pregnancy
• Iron deficiency is the commonest micronutrient disorder
causing anaemia in pregnancy
• Iron is a vital component for haematopoiesis
3

4. Why this study?
• Postpartum anaemia affects 50 – 80% of women in LMICs
• Increases risk of maternal complications such as
infection, poor wound healing, fatigue, and depression
and increase the risk of maternal death
• Oral iron is often used to treat it; blood transfusion
when severe
4

5. Why this study?
• Adherence to oral iron is reportedly poor
• Despite awareness, use of intravenous iron for anemia
treatment in obstetric units is not widespread in
Nigeria
• Earlier studies have found iron sucrose and ferric
carboxymaltose (FCM) to be more effective than oral
iron such as ferrous sulphate
5

6. Why this study?
• To determine if IV iron (FCM) that can be given
as single dose, is more effective and safe than
oral iron
• To determine its acceptability, and ease of
implementing its use in Nigerian hospital
contexts
6

7. Objectives
1.To determine the proportion of women who are non-
anemic (Hb level ≥ 11.0g/dl at six weeks postpartum
after treatment with intravenous ferric
carboxymaltose (FCM) versus oral ferrous sulphate (FS)
2.To determine the incidence of adverse drug events
including the incidence of hypophosphatemia in the
mother and adherence with the use of intravenous FCM
and oral FS for treatment of postpartum anemia
7

8. Objectives
3. To determine the acceptability of Intravenous FCM to
women and health care professionals
4. To determine the feasibility and organisational
readiness for implementing the use of intravenous FCM
in treating postpartum anemia in Nigeria
8

9. Study sites
9

10. The RCT
10

11. RCT outcome measures
Primary outcome
• Prevalence of non-anaemic state (Hb ≥ 11g/dl) at 6 wks
pp
Secondary outcomes
• Proportion of women with probable postpartum depression
at 6 wks & 6 months pp
• Change in mean pp Hb levels at 2 wks & 6 wks
• Prevalence of non-anaemic state (Hb ≥ 11g/dl) at 6
months pp
• Prev of moderate/severe anemia at 6 wks & 6 mths pp
11

12. RCT outcome measures
Secondary outcomes
• Change in iron panel parameters
• Need for blood transfusion post treatment until 6wks pp
• Prevalence of fatigue at 6 wks & 6 mths pp
• Proportion of women with secondary PPH after treatment.
• Proportion of infants being breastfed at 6 wks & 6 mths
pp
12

13. RCT outcome measures
Secondary outcomes
• Prevalence of impaired maternal-infant bonding at 6 wks
and 6 mths pp
• Incidence of till 6 wks pp
• Incidence of hypophosphatemia at 2 wks and 6 wks pp
• Incidence of other adverse drug events
• Quality of life using the WHO QOL bref
13

14. The IS aspect
14

15. IS outcome measures
• Acceptability of the intervention to women and health
care professionals
• Feasibility/organizational readiness for implementing
the intervention
15

16. 16

17. IVON-PP and the SDGs
• Improving maternal
health and reducing
maternal deaths from
postpartum anaemia
• Training 2 doctoral
students
• Improving research
skills of academicians
and health workers in
clinical trials 17

18. IVON-PP and the SDGs
• Significant proportion
of research teams
members are females to
promote gender equality
• Provision of employment
especially for Nigerian
youths
18

19. IVON-PP and the SDGs
• IVON-PP is novel in
Nigeria. The drug
ferric carboxymaltose
is new in Nigeria
• Bridge the global
inequalities in health
19

20. IVON-PP and the SDGs
• Fostered international collaborations between
BMGF, Nottingham University, LSTM, etc. and
UNILAG
• Promoting collaboration between Nigerian
universities (Bayero university, Kano,
University of Port Harcourt, Rivers,
University of Ilorin, kwara, and UNILAG)
• Promoting collaboration between public health
facilities at all levels of health care
20

21. 21

22. 22