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Completed

NCT Number: NCT03898440

Fetal Ano-genital Distance in 2D Ultrasound.

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.

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Key information

Conditions

Urogenital Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Male Urogenital Diseases Prenatal Disorder Sex Development Disorder Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Brest (Morvan)

Brest, 29200, France

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Ano-genital distance in mm

    Time frame: During fetal ultrasound exam

    the measure is correctly performed and validated by an expert

  3. Estimated fetal weight

    Time frame: During fetal ultrasound exam

    Impact of estimated fetal weight and anogenital distance

  4. neonatal sex determination

    Time frame: During fetal ultrasound exam

    concordance of anogenital distance and neonatal sex determination

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: DAG

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2019
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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