Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 2, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date April 15, 2019
Estimated Primary Completion Date April 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03898440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 11, 2019)
  • 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
  • Ano-genital distance in mm [ Time Frame: During fetal ultrasound exam ]
    the measure is correctly performed and validated by an expert
  • Estimated fetal weight [ Time Frame: During fetal ultrasound exam ]
    Impact of estimated fetal weight and anogenital distance
  • neonatal sex determination [ Time Frame: During fetal ultrasound exam ]
    concordance of anogenital distance and neonatal sex determination
Original Secondary Outcome Measures
 (submitted: March 29, 2019)
  • 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
  • feasibility of the measure [ Time Frame: During fetal ultrasound exam ]
    the measure is correctly performed and validated by an expert
  • Estimated fetal weight [ Time Frame: During fetal ultrasound exam ]
    Impact of estimated fetal weight and anogenital distance
  • neonatal sex determination [ Time Frame: During fetal ultrasound exam ]
    concordance of anogenital distance and neonatal sex determination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fetal Ano-genital Distance in 2D Ultrasound.
Official Title Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Urogenital Abnormalities
  • Prenatal Disorder
  • Sex Development Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2019)
318
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 5, 2022
Estimated Primary Completion Date April 5, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Anne-Hélène SALIOU +33298223333 anne-helene.saliou@chu-brest.fr
Contact: nne-Hélène SALIOU +33298223333 anne-helene.saliou@chu-brest.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03898440
Other Study ID Numbers 29BRC18.0067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: Anne-Hélène SALIOU CHRU Brest - Morvan hospital
PRS Account University Hospital, Brest
Verification Date July 2019