Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Concentration of cord blood phosphate in neonates
研究概览
简要总结
Iron deficiency anemia (IDA) is a very common health problem during pregnancy and intravenous (IV) iron substitution has become part of routine management. Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia (HP) in adults including pregnant women. The study aimed to evaluate the impact of IV iron administration during pregnancy on newborn's phosphatemia.
The investigators conducted a prospective, single-center, observational study in the Geneva University Hospitals (HUG), from September 2022 to March 2023. Pregnant women treated either with IV iron or with oral iron during pregnancy were included. At delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. Neonatal HP was defined as a phosphate level lower than 1.3 mmol/L.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Single pregnancy
- •Term (>37SA) pregnancy
- •Oral or IV iron substitution from second trimester
排除标准
- •Multiple pregnancy
- •Fetal anomalies
- •Preterm birth
研究组 & 干预措施
IV iron
干预措施: IV iron administration (Drug)
结局指标
主要结局
Concentration of cord blood phosphate in neonates
时间窗: Single timepoint at delivery
次要结局
未报告次要终点
研究者
Fanny Schumacher
resident doctor
University Hospital, Geneva
