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High disease activity and prednisone use during pregnancy; lifelong consequences for children of mothers with rheumatoid arthritis?

Completed
Conditions
chronic
systemic inflammatory disorder
10018424
10028920
Registration Number
NL-OMON40087
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
378
Inclusion Criteria

mother has participated in the PARA study (MEC 214.320/2002/117)

Exclusion Criteria

a) twins
b) non-Caucasian children
c) children with congenital abnormalities

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Anthropometric data of the child<br /><br>- Height<br /><br>- Weight<br /><br>- Sitting height<br /><br>- Head circumference<br /><br>- Arm/waist/hip circumference<br /><br><br /><br>Blood pressure of the child<br /><br>- 3 times measurement on one day<br /><br><br /><br>Parents:<br /><br>- weight<br /><br>- height<br /><br>- head circumference<br /><br>- blood pressure<br /><br><br /><br>Information on:<br /><br>- Familiy medical hisory<br /><br>- Medication use of mother<br /><br>- Growth chart from birth onwards</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Data on body composition & fat percentage<br /><br>- Lean body mass<br /><br>- Holtain skin fold caliper<br /><br>- Abdominal ultrasound<br /><br>- Dual Energy X-ray Absorptiometry (DXA)<br /><br><br /><br>Venapuncture<br /><br>- glucose<br /><br>- glucose fasting levels<br /><br>- C-peptide<br /><br>- Insulin<br /><br>- Cortisol<br /><br>- Total cholesterol<br /><br>- HDL<br /><br>- LDL<br /><br>- Triglycerides<br /><br>- Free fatty acid<br /><br>- Adiponectin<br /><br>- DNA analysis (genetic variation and epigenetic changes)<br /><br><br /><br>24 h cortisol levels in saliva<br /><br>- 4 measurements on one day<br /><br><br /><br>Buccal epithelial cells obtained by mouth swab<br /><br>- DNA analysis, 1 measurement</p><br>
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