Puberty in Girls Followed for Cystic Fibrosis (EPIMUCO)
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|ClinicalTrials.gov Identifier: NCT02562911|
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 14, 2017
In the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. The severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of children.
Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. Older patients were diagnosed during childhood. The optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. Most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults.
In literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers.
The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. The menstrual irregularity and amenorrhoea episodes concern nearly half of women.
On the pathophysiological level, studies in animals show that there is a direct effect of CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice.
The literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. There is to date no French cohort study on this topic.
The study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers Cystic Fibrosis two inter-region.
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Procedure: Data collection|
|Study Type :||Observational|
|Actual Enrollment :||166 participants|
|Official Title:||Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Procedure: Data collection
- Clinical examination
- Complete pelvic ultrasound abdominal ultrasound
- Bone age: X-ray
- biological examination
- Lung function assessed by the Maximum Volume Expired
- Brasfield radiological score (if available)
- The age of menarche in girls followed for cystic fibrosis in France [ Time Frame: Day 0 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562911
|CHU Besançon St Jacques|
|Hôpital des Enfants-Pellegrin|
|Canton- Hôpitaux de Brabois|
|American Memorial Hospital|
|Hôpital de Hautepierre|
|Hôpital des enfants Purpan|
|Principal Investigator:||Catherine PIENKOWSKI, MD||University Hospital, Toulouse|