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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
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.
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Exclusion Criteria
  • 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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Healthy female newbornsExternal genitalia measurements in female newbornsHealthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances
Primary Outcome Measures
NameTimeMethod
length of the clitorisDay 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
NameTimeMethod
clitoris widthDay 3

Measurement will be done if newborns stay at the hospital

anogenital ratioDay 3

Measurement will be done if newborns stay at the hospital

Blood level of testosteroneDay 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-hydroxyprogesteroneDay 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-androstenedioneDay 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-deoxycortisolDay 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 corticosteroneDay 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 dihydrotestosteroneDay 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

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