Fetal Ano-genital Distance in 2D Ultrasound. (DAG)
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|ClinicalTrials.gov Identifier: NCT03898440|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 18, 2019
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.
|Condition or disease|
|Urogenital Abnormalities Prenatal Disorder Sex Development Disorder|
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 Type :||Observational|
|Estimated Enrollment :||318 participants|
|Official Title:||Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||April 5, 2022|
|Estimated Study Completion Date :||April 5, 2022|
- fetal anogenital distance [ Time Frame: 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
- Interobserver variability [ Time Frame: During fetal ultrasound exam ]reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam
- Ano-genital distance in mm [ Time Frame: During fetal ultrasound exam ]the measure is correctly performed and validated by an expert
- Estimated fetal weight [ Time Frame: During fetal ultrasound exam ]Impact of estimated fetal weight and anogenital distance
- neonatal sex determination [ Time Frame: During fetal ultrasound exam ]concordance of anogenital distance and neonatal sex determination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898440
|Contact: Anne-Hélène SALIOUemail@example.com|
|Contact: nne-Hélène SALIOUfirstname.lastname@example.org|
|CHRU de Brest (Morvan)||Recruiting|
|Brest, France, 29200|
|Contact: Anne-Hélène Saliou +33298223333 email@example.com|
|Principal Investigator:||Anne-Hélène SALIOU||CHRU Brest - Morvan hospital|