Informations générales (source: ClinicalTrials.gov)
Study Protocol: Reference Values for External Genitalia and Androgen Blood Level in New Born Girls (VOGE)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
octobre 2014
août 2016
29 juin 2024
Normal values for female external genitalia size at birth, particularly clitoris and
blood level of androgens are not well known. This study's aim is to collect normal values
in 180 newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts
according to gestational age and birth weight.
The investigators will measure clitoris, genito-anal ratio using a small plastic caliper,
at birth, and their evolution until Day 3 of life (if the child is still at the
hospital).
The investigators also want to establish normal values of blood testosterone,
17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol,
deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone),
using samples taken for systematic post natal screening of diseases (only in new born of
35 or more weeks of birth).
This is an observational prospective study.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hopital Femme Mere Enfant - Bron - France | Claire-Lise Gay, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Healthy female newborns 24 to 41 weeks of pregnancy without sexual development
disturbances. Dysmature children - i.e. those with a - 2DS birth weight or height at
are not excluded.
- Healthy female newborns 24 to 41 weeks of pregnancy without sexual development
disturbances. Dysmature children - i.e. those with a - 2DS birth weight or height at
are not excluded.
- Sexual development abnormality, diagnosed pre- or post- birth, endocrine disorder,
obstetric trauma affecting genitalia, malformation syndrome, midline abnormalities,
congenital cancer, maternal ovary or adrenal tumor diagnosed during pregnancy,
mother or father's treatment during pregnancy likely to virilize the fetus, family
history of congenital adrenal hyperplasia or neurofibromatosis