Fetal Ano-genital Distance in 2D Ultrasound.

NCT03898440 | Completed

• 1 other identifier: DAG (29BRC18.0067)
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Urogenital Abnormalities; Prenatal Disorder; Sex Development Disorder

Keywords

anogenital distance; prenatal; sex determination; androgen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Interobserver variability

  During fetal ultrasound exam

• Ano-genital distance in mm

  During fetal ultrasound exam

• Estimated fetal weight

  During fetal ultrasound exam

• neonatal sex determination

  During fetal ultrasound exam

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• pregnant woman
• sonographic fetal follow up in Brest Hospital
• term\>18 weeks of gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest (Morvan)

Brest, 29200, France

Location

MeSH Terms

Conditions

Urogenital Abnormalities; Disorders of Sex Development

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Anne-Hélène SALIOU

  CHRU Brest - Morvan hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: April 15, 2019
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
• 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

Locations

FR (1)