Implementation and evaluation of an intravenous iron intervention for pregnant women with anaemia: a demonstration project

Phase 3

• Conditions: Anaemia; Iron deficiency; Pregnancy; Blood - Anaemia; Reproductive Health and Childbirth - Antenatal care; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12623001163695
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-09
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Pregnant women in the second or third trimester (13-32 weeks of gestation, dated by last menstrual period).
• Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10g/dL).
• Not known to have a diagnosis of thalassemia or other inherited red cell condition.
• Not known to have a prior allergy to intravenous iron.
• Clinically afebrile with no evidence of systemic infection.
• Resident in the study catchment area.

Exclusion Criteria

• Previous enrolment in EDIVA efficacy trial.
• Actively participating in another intervention trial.
• Known hypersensitivity to any of the study drugs.
• Any condition requiring hospitalisation in the next seven days or serious concomitant illness.
• Known history of thalassemia or other inherited red cell condition.
• Clinically low haemoglobin level requiring a blood transfusion (Hb <5g/dL).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% pregnant women with identified moderate or severe anaemia in the second or third trimester that received IV iron in primary care[as measured by study records end of study (12 months from the opening of the demonstration project)]