Fetal Ano-genital Distance in 2D Ultrasound. (DAG)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU de Brest (Morvan)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All pregnant women follow up at Brest Hospital to 18 weeks of gestation until term, except suspicion of fetal pelvic malformations and patients without an exact echographic datation of pregnancy between 11 and 13+6 weeks of gestation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Anne-Hélène SALIOU, CHRU Brest - Morvan hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): September 4, 2021
• Study Completion (ACTUAL): September 4, 2021

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (ACTUAL): April 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: prenatal; androgen; anogenital distance; sex determination
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Gonadal Disorders; Congenital Abnormalities; Disease; Urogenital Abnormalities; Disorders of Sex Development
• Other Study ID Numbers: DAG (29BRC18.0067)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No