Iron deficiency anaemia in pregnant women Pregnancy and Childbirth Iron deficiency anaemia in pregnancy
Conditions
Interventions
Current interventions as of 27/06/2022:
Eligible women will be admitted on a day case basis into the dedicated ward or day room for treatment initiation. They will be individually randomized in a 1:
Sponsors
University of Lagos
Eligibility
Sex/Gender
Female
Age
15 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 15 to 49 years old between 20- and 32-weeks’ gestational age 2. Baseline (enrolment) laboratory-confirmed moderate or severe anemia (Hb <10 g/dl)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/06/2022: 1. Medically confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months. 2. Severe symptomatic anemia needing urgent correction with blood transfusion. 3. Anemia of other cause besides IDA e.g., Sickle cell anemia. 4. Clinically confirmed malabsorption syndrome. 5. Hypersensitivity to any form of iron treatment. 6. History of any immune related illness e.g., SLE, Rheumatoid arthritis. 7. Preexisting maternal depression or other psychiatric illness. 8. Severe allergic reactions such as severe asthma. 9. History of severe drug allergy. _____ Previous exclusion criteria: 1. Medically confirmed significant bleeding, major surgery or received a blood transfusion within the last 3 months 2. Symptomatic anaemia with dyspnea or fatigue and a need for urgent correction 3. Concurrent anaemia of another cause besides IDA 4. Clinically-confirmed malabsorption syndrome or hypersensitivity to any form of iron treatment 5. Preexisting maternal depression or other psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/03/2022: 1. Prevalence of maternal anaemia (diagnosed as haemoglobin less than 11g/dl), at 36 weeks' gestation, measured with a haematological auto-analyser. 2. Incidence of preterm birth, measured at delivery. Previous primary outcome measure: 1. Prevalence of maternal anaemia (diagnosed as haemoglobin less than 11g/dl), at 36 weeks' gestation, measured with a haematological auto-analyser 2. Maternal haemoglobin levels measured using HemoCue at 4 weeks post-initiation of treatment and at delivery measured with a haematological auto-analyser | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/07/2023: 1. Safety and tolerability, including the incidence of hypophosphatemia and severity of maternal adverse effects measured using medical records at Day 1 and 4 weeks post enrolment, at 36 weeks gestational age and at 6 weeks post delivery; added 12/04/2021: serum phosphate concentration measured with laboratory assays using maternal blood and cord blood taken at delivery 2. Severe maternal events, specifically, haemorrhage, sepsis, shock and the need for blood transfusion measured using medical records at delivery 3. The incidence of low infant birth weight (<2.5 kg), prematurity (<37 weeks’ gestation as dated from the last menstrual period or a first-trimester ultrasound scan), stillbirth and neonatal mortality (birth till 28 days of life), the proportion of infants being breastfed at 1, 2 and 4 weeks of life, and receiving BCG, oral polio and hepatitis vaccination in the same time period, measured using medical records 4. Depression linked to the emotional well-being of mothers measured using the validated Edinburgh Postnatal Depression Scale at enrolment, 36 weeks gestational age and 7 days post delivery 5. Maternal haemoglobin levels measured using HemoCue at 4 weeks post-initiation of treatment and at delivery measured with a haematological auto-analyser 6. Prevalence of maternal iron deficiency (diagnosed by serum ferritin level less than 30 ng/ml) at 36 weeks' gestation measured using laboratory assay Previous secondary outcome measures from 14/03/2022 to 20/07/2023: 1. Safety and tolerability, including the incidence of hypophosphatemia and severity of maternal adverse effects measured using medical records at Day 1 and 4 weeks post enrolment, at 36 weeks gestational age and at 6 weeks post delivery; added 12/04/2021: serum phosphate concentration measured with laboratory assays using maternal blood and cord blood taken at delivery 2. Severe maternal events, specifically, haemorrhage, sepsis, shock and th | — |
Countries
Nigeria
Contacts
Public ContactOchuwa Babah
Outcome results
None listed