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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children of rheumatic diseased mothers not on treatment |
| ||
| children of rheumatic diseased mothers on antimalarial drugs |
| ||
| children of normal mothers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiometer | Diagnostic Test | detection of hearing problems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dual channel audiometer | 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. | 20 mimutes |
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Inclusion Criteria:
Exclusion Criteria:
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children (age 4 to 16 years) whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Salama Bakr, Professor | Contact | 1006550289 | +20 | mohamedsalamabakr@yahoo.com |
| Amira Mohammad A.Eloseily, Lecturer | Contact | 1095495110 | +20 | Amira_oseily@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Ragab mohasseb, Phd | Assiut University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26940667 | Background | 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. |
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| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |