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临床试验/NCT06108258
NCT06108258已完成不适用

Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年9月23日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fanny Schumacher

resident doctor

University Hospital, Geneva

研究点 (1)

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