Fetal Ano-genital Distance in 2D Ultrasound.

Completed

• Conditions: Urogenital Abnormalities; Prenatal Disorder; Sex Development Disorder

• Registration Number: NCT03898440
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed 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?

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Study Start: 2019-04-15
• Status Verified: 2021-01
• Primary Completion: 2021-09-04
• Study Completion: 2021-09-04
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 318

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal anogenital distance	During fetal ultrasound exam	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

Secondary Outcome Measures

Name	Time	Method
Ano-genital distance in mm	During fetal ultrasound exam	the measure is correctly performed and validated by an expert
Estimated fetal weight	During fetal ultrasound exam	Impact of estimated fetal weight and anogenital distance
Interobserver variability	During fetal ultrasound exam	reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam
neonatal sex determination	During fetal ultrasound exam	concordance of anogenital distance and neonatal sex determination

Trial Locations

Locations (1)

CHRU de Brest (Morvan); 🇫🇷 Brest, France