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

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)0 个研究点目标入组 900 人开始时间: 2021年7月23日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•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).

•- 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

发起方

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