Retrospective Analysis of the Neonatal Management of Patients with an Antenatal Diagnosis of Genital Development Variation At the Hospital of Lyon (PECAN-VDG)

November 12, 2024 updated by: Hospices Civils de Lyon

Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development At Lyon Hospital

Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected.

The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth.

The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally.

The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years.

The secondary objectives are :

  • To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis.
  • To characterize prenatally diagnosed Disorders of Sexual Development
  • To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up.

  • The evaluation of the care pathway :

    • To establish the frequency of prenatal psychological support for parents
    • To establish the role of parents in prenatal diagnosis strategy decisions at our center

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service d'endocrinologie pédiatrique HFME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All fetuses referred to the hospital Femme-Mère-Enfant and the hospital Croix Rousse Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs), for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from 01/01/2013 to 31/12/2023.

Description

Inclusion Criteria:

Fetuse of the hospital Femme-Mère-Enfant, the hospital Croix Rousse and Lyon-Sud hospital, reffered to Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs) for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from January 2013 to December 2022.

Intrauterine growth retardation (RCIU), a muscular or minor ventricular septal defect, or a pyloric dilatation are not considered as an associated malformation.

Exclusion Criteria:

  • No follow-up file at the CPDPN of the hospital Femme-Mère-Enfant, the hospital Croix Rousse or of Lyon-Sud hospital.
  • Lack of data and identification of the child born.
  • Referred to CPDPN for urinary malformation including no VDG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All fetuses referred to the HFME and Croix Rousse CPDPNs for antenatal diagnostic consultation (DAN)
Non-interventional retrospective study, only on datas for suspected isolated variation in genital development (VDG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development at Lyon Hospital
Time Frame: From January 2013 to December 2022.
Number and type of complementary investigations performed as part of antenatal management following ultrasound diagnoses of Disorders of Sexual Development over the past 10 years.
From January 2013 to December 2022.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_5313

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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