Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: i-Pregnant Women aged 15 – 49 years between 13 to 28weeks’ gestation ii- Pregnant women with Hb <10g/dl or Pack cell volume <30% iii-Willing and able to give consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Medically confirmed significant bleeding, major surgery, or blood transfusion within the last 3 months 2. Severe symptomatic anaemia requiring blood transfusion 3. Anaemia confirmed to be from other known causes besides IDA, e.g. sickle cell anaemia 4. Clinically confirmed malabsorption syndrome 5. Hypersensitivity or known allergy to any forms of iron or known severe drug allergies 6. Severe allergic reactions such as severe asthma 7. History of autoimmune disease, e.g. systemic lupus erythematosus, rheumatoid arthritis 8. Patients with severe, acute or chronic, hepatic or renal failure, severe cardiac insufficiency. 9. Patients with complications like bleeding piles, excessive emesis, active peptic ulcer disease, diabetes mellitus, hypertension, eclampsia, hypothyroidism, hyperthyroidism, and evidence of any malabsorption diseases 10. Patients with acute febrile illness such as malaria 11. Patients with multiple gestation 12. Patients who has been on haematinics prior to antenatal booking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Increase in haemoglobin level (Hb) from enrolment baseline to 12 weeks after commencement of therapy. b. Change in RBC indices such as MCV,MCH,MCHC. c .Preterm birth | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Efficacy and Safety of the study medication b.Need for blood transfusion c.Occurrence of adverse drug reactions such as vomiting, diarrhoea, epigastric pain, constipation, metallic taste, and dizziness d. Infant outcomes: birthweight, Apgar score, neonatal mortality. | — |
Countries
Nigeria
Contacts
consultant