Urogenital AbnormalitiesDAGNCT03898440
Fetal Ano-genital Distance in 2D Ultrasound.
An observational study of Urogenital Abnormalities and Prenatal Disorder, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urogenital Abnormalities, Prenatal Disorder, Sex Development Disorder
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2019to 4 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- pregnant woman
- sonographic fetal follow up in Brest Hospital
- term>18 weeks of gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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?
- Keywords
- anogenital distance, prenatal, sex determination, androgen
- Medical subject headings
- Urogenital Abnormalities, Disorders of Sex Development
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During fetal ultrasound exam
Secondary outcomes (4)
Interobserver variability
reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam
Measured: During fetal ultrasound exam
Ano-genital distance in mm
the measure is correctly performed and validated by an expert
Measured: During fetal ultrasound exam
Estimated fetal weight
Impact of estimated fetal weight and anogenital distance
Measured: During fetal ultrasound exam
neonatal sex determination
concordance of anogenital distance and neonatal sex determination
Measured: During fetal ultrasound exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start15 Apr 2019
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urogenital AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Hélène SALIOU, Principal investigator, CHRU Brest - Morvan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898440
- Sponsor's protocol ID
- DAG (29BRC18.0067)
- Acronym
- DAG
- Status last verified
- Jan 2021
- First submitted
- 29 Mar 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.
- ClinicalTrials.gov ID
- NCT03898440
- Acronym / sponsor ID
- DAG / DAG (29BRC18.0067)
- Keywords
- anogenital distance, prenatal, sex determination, androgen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- pregnant woman
- sonographic fetal follow up in Brest Hospital
- term>18 weeks of gestation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Interobserver variability
Time frame: During fetal ultrasound exam
Ano-genital distance in mm
Time frame: During fetal ultrasound exam
Estimated fetal weight
Time frame: During fetal ultrasound exam
neonatal sex determination
Time frame: During fetal ultrasound exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Hélène SALIOU principal investigator
CHRU Brest - Morvan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urogenital Abnormalities and Prenatal Disorder, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal anogenital distance (time frame: During fetal ultrasound exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.