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Hearing Problems in Children of Rheumatic Diseased Mothers

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03666910
Enrollment
90
Registered
2018-09-12
Start date
2018-10-31
Completion date
2019-12-31
Last updated
2018-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Disorders

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTAudiometer

detection of hearing problems

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Dual channel audiometer20 mimutesevaluate 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.

Contacts

Primary ContactMohamed Salama Bakr, Professor
mohamedsalamabakr@yahoo.com1006550289
Backup ContactAmira Mohammad A.Eloseily, Lecturer
Amira_oseily@yahoo.com1095495110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026