Children follow-up study of PCOS women

Children follow-up study of PCOS women - CHOPS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39806

Enrollment

100

Registered

2012-08-13

Start date

2012-12-31

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

PCOS polycystic ovary syndrome

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Cases: -Children of mothers with PCOS at the age of 2.5-4 years or 5-8 years;Controls: -Children with the age of 2.5-4 years or 5-8 years -Mothers of these children must have had a regular cycle and conceived naturally

Exclusion criteria

Exclusion criteria: -Language barrier -Children with a history of a heart defect -Children with a respiratory infection or respiratory infection two weeks previous to the visit (they are asked to reschedule the appointment) -Residency outside the Netherlands -Children with Diabetes Mellitus type I -Children with unresolved medical conditions

Design outcomes

Primary

Measure	Time frame
Primary study parameter/endpoint: To determine cardiovascular health in offspring of PCOS mothers during childhood and to compare it with children from non-PCOS mothers. The main study parameters consist of cardiovascular measurements. • Age of 2.5-4 years: Physical examination: anthropometry, blood pressure Cardiovascular parameters: pulse wave velocity, echocardiography (systolic and diastolic function of the right and left ventricle) Sample: saliva sample • Age of 5-8 years: Physical examination: anthropometry, blood pressure Cardiovascular parameters: intra-abdominal and subcutaneous fat, carotid intima media thickness (CIMT), vascular stiffness. Samples: serum, saliva sample	—

Measure

Time frame

Primary study parameter/endpoint: To determine cardiovascular health in offspring of PCOS mothers during childhood and to compare it with children from non-PCOS mothers. The main study parameters consist of cardiovascular measurements. • Age of 2.5-4 years: Physical examination: anthropometry, blood pressure Cardiovascular parameters: pulse wave velocity, echocardiography (systolic and diastolic function of the right and left ventricle) Sample: saliva sample • Age of 5-8 years: Physical examination: anthropometry, blood pressure Cardiovascular parameters: intra-abdominal and subcutaneous fat, carotid intima media thickness (CIMT), vascular stiffness. Samples: serum, saliva sample

—

Secondary

Measure	Time frame
To determine pulmonary health in offspring of PCOS mothers during childhood and to compare it with children from non-PCOS mothers: • Age of 2.5-4 years: Pulmonary parameters: Interrupter resistance (Rint®) • Age of 5-8 years: o Pulmonary parameters: interrupter resistance (Rint®), spirometry, inflammatory markers (nitric oxide) in exhaled air	—

Countries

Netherlands

Outcome results