Genitalia and Androgen in New Born Girls
- Conditions
- Newborn Genitalia
- Interventions
- Other: External genitalia measurements in female newborns
- Registration Number
- NCT02826278
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 180
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy female newborns External genitalia measurements in female newborns Healthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances
- Primary Outcome Measures
Name Time Method length of the clitoris Day 3 The measurement is performed on the supine child, with flexed hips and knees retained by the nurse or the nursery nurse. The clitoris will be delimited using cavernosa palpation. The clitoris length will be measured from maxima lablias'root to the top of clitoris, excluding cutaneous cover. Measurements are performed using an-8 cm plastic caliper
- Secondary Outcome Measures
Name Time Method clitoris width Day 3 Measurement will be done if newborns stay at the hospital
anogenital ratio Day 3 Measurement will be done if newborns stay at the hospital
Blood level of testosterone Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Blood level of 17-hydroxyprogesterone Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Blood level of delta4-androstenedione Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Blood level of 21-deoxycortisol Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Blood level of corticosterone Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Blood level of dihydrotestosterone Day 3 This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA
Trial Locations
- Locations (1)
Hopital Femme Mere Enfant
🇫🇷Bron, France