Iron deficiency anaemia in postpartum women Pregnancy and Childbirth
Conditions
Interventions
Postpartum women during 6-48 hours of delivery will be screened. Eligible women on the ward will be individually randomized in a 1:1 ratio to receive either intravenous ferric carboxymaltose or oral i
1 hour before meals or 2 hours after meals with a full glass of water till 6 weeks postpartum. All participants will be followed up subsequently till 6 months postpartum.
Sponsors
University of Lagos
Eligibility
Sex/Gender
Female
Age
15 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 15 and 49 years 2. Between 6 and 48 hours after delivery 3. Baseline (enrollment) moderate or severe anemia (Hb = 9.9g/dl), confirmed by Hemocue haemoglobinometer 4. Able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Having received a blood transfusion, for any indication, within the last 3 months 2. Symptomatic anemia and a need for urgent correction 3. Known haemoglobinopathy such as sickle cell disease, HbCC disease 4. Clinically confirmed malabsorption syndrome 5. Known hypersensitivity or contraindication to any form of iron treatment, study drug or any of its excipients 6. Self-reported pre-existing maternal depression or other psychiatric illness and as evidenced by a YES response to any past history of psychiatry ward hospitalization, psychiatry medications, behavioral changes, or past consultation with psychiatry services 7. Severe allergic conditions such as severe asthma, eczema or other atopic condition 8. Known autoimmune conditions e.g., systemic lupus erythematosus, rheumatoid arthritis or known severe drug allergies. 9. Planning to move or reside outside the research area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 31/07/2024: Proportion of participants who are anemic at six weeks postpartum. An anemic state is defined as hemoglobin level of < 11.0 g/dL, measured using haemoglobin levels at 6weeks postpartum ____ Previous primary outcome measure: Proportion of participants who are non-anaemic at six weeks postpartum. Non-anaemic state is defined as haemoglobin level = 11.0g/dl, measured using haemoglobin levels at 6weeks postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of women with postpartum depression, measured using the Edinburgh Postnatal Depression Scale at six weeks and six months postpartum. 2. Change in mean postpartum haemoglobin levels at two weeks and six weeks postpartum, measured using haemoglobin levels at two weeks and six weeks. 3. Achievement of a non-anaemic state (Hb=11.0g/dl) at six months postpartum, measured using haemoglobin levels at six months. 4. Prevalence of moderate/severe anaemia at six weeks and six months postpartum, measured using haemoglobin levels at six weeks and six months. Moderate anaemia is defined as haemoglobin level 7.0-9.9 g/dl and severe anaemia as haemoglobin level 5. Change in mean serum ferritin, serum transferrin, serum iron and % transferrin saturation at two weeks and six weeks postpartum. 6. Need for blood transfusion after iron treatment during the first 6 weeks postpartum. 7. Prevalence of fatigue at six weeks and six months postpartum, measured using the Fatigue Severity Scale (revised FSS-5R version). 8. Proportion of women with secondary postpartum haemorrhage after treatment. This will be defined as excessive bleeding requiring surgical intervention or blood transfusion from 24 hours after delivery till 12 weeks postpartum. 9. Proportion of infants being breastfed (exclusive and any) at six weeks and six months postpartum. 10. Prevalence of impaired maternal-infant bonding at six weeks and six months postpartum measured using the Mother-to-Infant Bonding Scale at six weeks and six months postpartum. 11. Incidence confirmed or suspected maternal infection within 6 weeks of birth, as defined by a new prescription of antibiotics for presumed perineal wound-related infection, endometritis or uterine infection, urinary tract infection or other systemic infection (clinical sepsis). 12. Incidence of hypophosphatemia at two weeks and six weeks postpartum. Measurement of vitamin D, alkaline phosphatase, P1NP, FGF23, Ca, PO4, which are biomarkers of phosphorus homeost | — |
Countries
Nigeria
Contacts
Public ContactVictoria Adaramoye
Outcome results
None listed