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临床试验/CTRI/2022/11/047102
CTRI/2022/11/047102进行中(未招募)未知

euroimaging Ancillary Study of the IV Iron RAPIDIRON Trial

Bill and Melinda Gates Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • a. For the maternal participant in the RAPIDIRON Trial â?? a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age);
  • b. An indication of the pregnant womanâ??s intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
  • c. Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in the ancillary trial;
  • d. Concurrent participation in the RAPIDIRON-KIDS follow-up study.

排除标准

  • a. If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
  • b. If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.

研究者

发起方
Bill and Melinda Gates Foundation

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