ACTRN12618001268235
Active, not recruiting
Phase 3
Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women
niversity of Malawi, College of Medicine0 sites862 target enrollmentJuly 27, 2018
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Malawi, College of Medicine
- Enrollment
- 862
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants meeting the following criteria will be included in the trial:
- •1\.Confirmed singleton pregnancy at 13\-26 weeks gestation
- •2\.Moderate to severe anaemia not requiring an immediate blood transfusion (Hb \<10g/dl)
- •3\.Negative malaria parasitaemia
- •4\.Resident in the study catchment area of Blantyre and Zomba district
- •5\.Plan to deliver at a health facility
- •6\.Written informed consent (including assent if \<18 years old)
Exclusion Criteria
- •1\.Hypersensitivity to any of the study drugs
- •2\.Clinical symptoms of malaria or bacterial infection
- •3\.Any condition requiring hospitalization or serious concomitant illness
- •4\.Chronic illness that may adversely affect foetal growth and viability
- •5\. Low haemoglobin with symptomatic severe anaemia, requiring a blood transfusion (usually Hb \<5g/dl)
- •6\.Previous history of pre\-eclampsia
Outcomes
Primary Outcomes
Not specified
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