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Fetal Ano-genital Distance in 2D Ultrasound.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03898440
Acronym
DAG
Enrollment
318
Registered
2019-04-02
Start date
2019-04-15
Completion date
2021-09-04
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prenatal Disorder, Sex Development Disorder, Urogenital Abnormalities

Keywords

anogenital distance, prenatal, sex determination, androgen

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?

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
fetal anogenital distanceDuring fetal ultrasound examThe 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

MeasureTime frameDescription
Interobserver variabilityDuring fetal ultrasound examreproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam
Ano-genital distance in mmDuring fetal ultrasound examthe measure is correctly performed and validated by an expert
Estimated fetal weightDuring fetal ultrasound examImpact of estimated fetal weight and anogenital distance
neonatal sex determinationDuring fetal ultrasound examconcordance of anogenital distance and neonatal sex determination

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026