2024-512064-61-00已完成4 期
Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Hb levels at 4 weeks post IMP treatment
研究概览
简要总结
To determine whether alternate day oral iron is noninferior to daily oral iron for the treatment of iron deficiency anaemia by comparing haemoglobin level (Hb) between the two arms after 4 weeks of therapy
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
- •Subjects must be aged 18 years or above at visit 1
- •Subjects will need to have a standard of English good enough to understand and read the information leaflet and consent form and communicate easily with the research team
- •A diagnosis of IDA as defined by Hb <10.5g/dL but not ≤7g/dl and a serum ferritin of <30µg/L
- •Singleton pregnancies
- •Gestational age of 14- 34 weeks’ gestation
- •A level of English high enough for informed consent and study participation
排除标准
- •Women <18 years of age
- •Allergy/sensitivity to Galfer or their ingredients
- •Subjects unable to provide written informed consent or who require an interpreter
- •Known haemoglobinopathy
- •Severe anaemia as defined by Hb ≤7g/dl
- •Subjects who have any other significant disease or disorder (including inflammatory bowel disease, haemochromatosis, haemoglobinopathy, any active inflammatory diseases, malabsorptive conditions) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
- •Any underlying medical disorder or medications that the research team feel would impact iron absorption eg. Hyperemesis, Coeliac’s disease, inflammatory bowel disease, anaemia of chronic disease or anaemia related to other causes (B12/Folate), previous bariatric surgery, active PUD, haemochromatosis
- •Multiple pregnancy
- •Not taking medications in a way which could potentially hinder the absorption of iron eg. PPIs, Antacids, levothyroxine all need to be taken separately to iron
结局指标
主要结局
Hb levels at 4 weeks post IMP treatment
Hb levels at 4 weeks post IMP treatment
次要结局
- Compliance as measured by objective pill count at 4 week assessment
- Serum ferritin levels in both groups after 4 weeks treatment
- Compliance as measured by questionnaire at 4 week assessment
- Tolerance as measured by gastrointestinal symptom questionnaire at 4 week assessment
- Obstetric and neonatal outcomes : o Delivery outcomes (livebirth, stillbirth, NND) o Mode of delivery (OVD, SVD, LSCS) o Rates and quantitation of primary PPH o Postnatal blood transfusion in the two weeks post-delivery (Y/N, if yes for RCC no. of units) o Postnatal iron transfusion in the two weeks post-delivery o Neonatal Intensive Care Unit admission (Y/N) o Apgar scores (at 1 and 5 minutes of life as standard) o Birth weights o Most recent Hb levels at term (37-42 wks gestation)
研究者
Gráinne O'Reilly
Scientific
University College Dublin
研究点 (1)
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