Hearing Problems in Children of Rheumatic Diseased Mothers
Assessment of Hearing in Children Born to Rheumatic Diseased Women Treated With Antimalarial Drugs During Pregnancy
1 other identifier
observational
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 12, 2018
September 1, 2018
1 year
September 10, 2018
September 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
children of rheumatic diseased mothers not on treatment
children of rheumatic diseased mothers on antimalarial drugs
children of normal mothers
Interventions
detection of hearing problems
Eligibility Criteria
children (age 4 to 16 years) whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.
You may qualify if:
- children males \& females
- Age 4 to 16 years.
- whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26940667BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatma Ragab mohasseb, Phd
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
October 1, 2018
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
September 12, 2018
Record last verified: 2018-09