Efficacy and Demonstration of IntraVenous Iron for Anaemia in pregnancy (EDIVA)

Phase 3

Recruiting

• Conditions: Anaemia; Iron deficiency; Maternal depression; Low birthweight; Prematurity; small for gestational age; Blood - Anaemia; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Diet and Nutrition - Other diet and nutrition disorders; Mental Health - Depression

• Registration Number: ACTRN12621000968875
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-23
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

In their second (13-25 completed weeks) or third trimester (26-32 completed weeks of gestation), dated by Last Menstrual Period.
- Moderate to severe anaemia (capillary Hb <10g/dL).
- Not known to have a multiple pregnancy.
- Expected to deliver the baby inside or within 30 minutes of road transport of the study catchment area.
- Have drinking water iron <2mg/L.
- Willing to provide written informed consent (if the pregnant woman is <18 years of age, consent will be collected from her guardian, while she will sign an assent form).

Exclusion Criteria

- Women visiting the region temporarily or expecting to travel out of the study site for more than one month over the subsequent 12 months.
- Women expecting to deliver their baby outside the study region.
- Known to have a diagnosis of thalassemia or other inherited red cell condition.
- Known to have a prior allergy to intravenous iron.
- Women with high drinking groundwater iron.
- Women with severe anaemia requiring an emergency blood transfusion (Hb <5g/dL), or with haemodynamic or acute clinical compromise as judged by a study physician.
- Known hypersensitivity to any of the study drugs.
- Clinical symptoms of current bacterial/viral infection (e.g.fever).
- Any condition requiring urgent hospitalization or serious concomitant illness.
- Women in the third trimester of pregnancy currently already enrolled in the second trimester of the EDIVA Activity 2.
- Women who have already received a dose of intravenous iron during the current pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified