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Clinical Trials/ACTRN12623001163695
ACTRN12623001163695
Not yet recruiting
Phase 3

Implementation and evaluation of an intravenous iron intervention for pregnant women with moderate and severe anaemia in the primary healthcare system of Bangladesh: a demonstration project

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)0 sites2,000 target enrollmentNovember 9, 2023
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ConditionsAnaemiaIron deficiencyPregnancyBlood - AnaemiaReproductive Health and Childbirth - Antenatal careReproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anaemia
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Enrollment
2000
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 9, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Not specified

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