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

High disease activity and prednisone use during pregnancy; lifelong consequences for children of mothers with rheumatoid arthritis? - FEtal Programming by Rheumatoid Arthritis (FEPRA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40087

Enrollment

378

Registered

2009-12-21

Start date

2010-10-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

chronic systemic inflammatory disorder

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Anthropometric data of the child - Height - Weight - Sitting height - Head circumference - Arm/waist/hip circumference Blood pressure of the child - 3 times measurement on one day Parents: - weight - height - head circumference - blood pressure Information on: - Familiy medical hisory - Medication use of mother - Growth chart from birth onwards	—

Secondary

Measure	Time frame
Data on body composition & fat percentage - Lean body mass - Holtain skin fold caliper - Abdominal ultrasound - Dual Energy X-ray Absorptiometry (DXA) Venapuncture - glucose - glucose fasting levels - C-peptide - Insulin - Cortisol - Total cholesterol - HDL - LDL - Triglycerides - Free fatty acid - Adiponectin - DNA analysis (genetic variation and epigenetic changes) 24 h cortisol levels in saliva - 4 measurements on one day Buccal epithelial cells obtained by mouth swab - DNA analysis, 1 measurement	—

Measure

Time frame

Data on body composition & fat percentage - Lean body mass - Holtain skin fold caliper - Abdominal ultrasound - Dual Energy X-ray Absorptiometry (DXA) Venapuncture - glucose - glucose fasting levels - C-peptide - Insulin - Cortisol - Total cholesterol - HDL - LDL - Triglycerides - Free fatty acid - Adiponectin - DNA analysis (genetic variation and epigenetic changes) 24 h cortisol levels in saliva - 4 measurements on one day Buccal epithelial cells obtained by mouth swab - DNA analysis, 1 measurement

—

Countries

Netherlands

Outcome results