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临床试验/NCT03666910
NCT03666910Unknown不适用

Assessment of Hearing in Children Born to Rheumatic Diseased Women Treated With Antimalarial Drugs During Pregnancy

Assiut University0 个研究点目标入组 90 人开始时间: 2018年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
Dual channel audiometer

研究概览

简要总结

Evaluation of the hearing functions of children born to rheumatic diseased mothers who received gestational antimalarial drugs versus those didn't receive gestational antimalarials drugs compared with normal healthy children.

详细描述

Rheumatic diseases are autoimmune illnesses characterized by tissue damage, caused by abnormal immunologic reaction against own cells, tissues or organs.Many of these rheumatic diseases preferentially occur in women during the childbearing age.

The transplacental passage of maternal antibody may result in a variety of adverse fetal effects including thrombocytopenia, neutropenia, hemolysis and thyroid disease. Both fetal hypo and hyper thyroidism may occur and maternal hypothyroidism particularly during the 1st trimester is associated with impaired fetal neurological development and delayed mental and motor development.

Hydroxychloroquine (CQ), the hydroxyl derivative of chloroquine, is an antimalarial agent which is widely used, either alone or in combination with other agents, in the treatment of SLE, rheumatoid arthritis (RA) and various other autoimmune diseases.

Hydroxychloroquine is safe during pregnancy, as it is not associated with an increased rate of congenital malformations. However, isolated cases of ocular (retinal pigment deposits) and auditory abnormalities were reported.

An increase in high-frequency hearing threshold is the earliest change in the auditory function for most drug induced hearing losses, including the irreversible damage caused by antimalarials.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children males & females
  • Age 4 to 16 years.
  • whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.

排除标准

  • Prematurity, history of prenatal, natal or post natal medical problems.
  • Family history +ve.
  • Consanguinity +ve.
  • Gestational intake of other ototoxic drugs.
  • Use of antimalarial due to diseases other than rheumatic diseases.
  • Administration of antimalarial before pregnancy.
  • Children who have middle ear disorders.

结局指标

主要结局

Dual channel audiometer

时间窗: 20 mimutes

evaluate the hearing functions of children born to rheumatic diseased mothers who received gestational antimalarial drugs versus those didn't receive gestational antimalarials drugs compared with normal healthy children.

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

Fatma Ragab Mohasseb Ali

Principle investigator

Assiut University

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