Genitalia and Androgen in New Born Girls (VOGE)

Study Protocol: Reference Values for External Genitalia and Androgen Blood Level in New Born Girls

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.

Study Overview

• Status: Unknown
• Conditions: Newborn Genitalia
• Intervention / Treatment: Other: External genitalia measurements in female newborns

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Claire-Lise GAY, MD; Phone Number: +33 472 129 531; Email: claire-lise.gay@chu-lyon.fr
• Study Contact Backup: Name: Cornu Catherine, MD; Phone Number: +33 472 357 231; Email: catherine.cornu@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Recruiting
    • Hopital Femme Mere Enfant
    • Contact: Claire-Lise Gay, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female newborns, with gestational ages of 24 to 41 weeks of pregnancy.

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy female newborns; Healthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances	Other: External genitalia measurements in female newborns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of the clitoris	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.	Day 1
length of the clitoris	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	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clitoris width	The clitoris will be measured at its base, using an-8 cm plastic caliper.	Day 1
clitoris width	Measurement will be done if newborns stay at the hospital	Day 3
anogenital ratio	The ano-genital ratio is the ratio between 1) the distance from anus center to the base of clitoris and 2) the distance from anus center and the posterior commissure of the vulva frenulum.	Day 1
anogenital ratio	Measurement will be done if newborns stay at the hospital	Day 3
Blood level of testosterone	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	Day 3
Blood level of 17-hydroxyprogesterone	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	Day 3
Blood level of delta4-androstenedione	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	Day 3
Blood level of 21-deoxycortisol	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	Day 3
Blood level of corticosterone	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	Day 3
Blood level of dihydrotestosterone	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	Day 3

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire-Lise GAY, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2016
• Study Completion (ANTICIPATED): August 1, 2016

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Newborn genitalia; reference charts
• Other Study ID Numbers: 69HCL14_0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO