Hearing Disorders Clinical Trial
Official title:
Assessment of Hearing in Children Born to Rheumatic Diseased Women Treated With Antimalarial Drugs During Pregnancy
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.
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.
The investigators therefore will use audiological methods for detection of hearing impairment
in children delivered for mothers receiving antimalarials during pregnancy with rheumatic
diseases.
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