Fetal Ano-genital Distance in 2D Ultrasound.

Prenatal Disorder Clinical Trial

— DAG  

Official title:

Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898440
• Other study ID #: DAG (29BRC18.0067)
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: September 4, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date.

The study also evaluates the feasibility of the measure and its interobserver variability.

Description:

The anogenital distance of female newborns is shorter than that of male newborns.

Urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance.

Anogenital distance is a good marker of fetal exposure to androgenic substances.

Prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis).

Is the anogenital distance easy to make measure? Can this procedure be reproduced? What are the threshold values to determine fetal sex at each term of pregnancy?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: September 4, 2021
• Est. primary completion date: September 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant woman

• sonographic fetal follow up in Brest Hospital

• term>18 weeks of gestation

Exclusion Criteria:

• No datation between 11 weeks of gestation and 13 weeks of gestation and 6 days by crown-rump length measurement

• Minor

• no consent

• ultrasound performed by an operator without ultrasonography graduation

Related Conditions & MeSH terms

• Disease
• Disorders of Sex Development
• Prenatal Disorder
• Sex Development Disorder
• Urogenital Abnormalities

Locations

Country	Name	City	State
France	CHRU de Brest (Morvan)	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal anogenital distance	The distance will be measured from the center of the anus to the posterior convergence of the fourchette in female fetuses and to the posterior base of the scrotum in male fetuses	During fetal ultrasound exam
Secondary	Interobserver variability	reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam	During fetal ultrasound exam
Secondary	Ano-genital distance in mm	the measure is correctly performed and validated by an expert	During fetal ultrasound exam
Secondary	Estimated fetal weight	Impact of estimated fetal weight and anogenital distance	During fetal ultrasound exam
Secondary	neonatal sex determination	concordance of anogenital distance and neonatal sex determination	During fetal ultrasound exam