Fetal Ano-genital Distance in 2D Ultrasound.

NCT ID: NCT03898440

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2021-09-04

Brief Summary

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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

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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?

Conditions

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Urogenital Abnormalities Prenatal Disorder Sex Development Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Hélène SALIOU

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest - Morvan hospital

Locations

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CHRU de Brest (Morvan)

Brest, , France

Site Status

Countries

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France

Other Identifiers

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DAG (29BRC18.0067)

Identifier Type: -

Identifier Source: org_study_id

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