Hearing Problems in Children of Rheumatic Diseased Mothers
NCT ID: NCT03666910
Last Updated: 2018-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2018-10-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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children of rheumatic diseased mothers not on treatment
Audiometer
detection of hearing problems
children of rheumatic diseased mothers on antimalarial drugs
Audiometer
detection of hearing problems
children of normal mothers
Audiometer
detection of hearing problems
Interventions
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Audiometer
detection of hearing problems
Eligibility Criteria
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Inclusion Criteria
* Age 4 to 16 years.
* whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.
Exclusion Criteria
* 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.
4 Years
16 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Fatma Ragab Mohasseb Ali
Principle investigator
Principal Investigators
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Fatma Ragab mohasseb, Phd
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Baldwin C, Avina-Zubieta A, Rai SK, Carruthers E, De Vera MA. Disease-modifying anti-rheumatic drug use in pregnant women with rheumatic diseases: a systematic review of the risk of congenital malformations. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):172-83. Epub 2016 Mar 3.
Other Identifiers
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17100500
Identifier Type: -
Identifier Source: org_study_id
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