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

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ClinicalTrials.gov Identifier: NCT03898440
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.


Condition or disease
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?


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Study Type : Observational
Estimated Enrollment : 318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : April 5, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898440


Contacts
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Contact: Anne-Hélène SALIOU +33298223333 anne-helene.saliou@chu-brest.fr
Contact: nne-Hélène SALIOU +33298223333 anne-helene.saliou@chu-brest.fr

Locations
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France
CHRU de Brest (Morvan) Recruiting
Brest, France, 29200
Contact: Anne-Hélène Saliou    +33298223333    anne-helene.saliou@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Anne-Hélène SALIOU CHRU Brest - Morvan hospital

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03898440     History of Changes
Other Study ID Numbers: 29BRC18.0067
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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

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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

Keywords provided by University Hospital, Brest:
anogenital distance
prenatal
sex determination
androgen

Additional relevant MeSH terms:
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Disease
Urogenital Abnormalities
Disorders of Sex Development
Pathologic Processes
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases