NCT04983069

Brief Summary

Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria. A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal. The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

July 5, 2021

Last Update Submit

November 12, 2021

Conditions

ColicNephropathy

Keywords

Gynecology-ObstetricsUltrasoundMedical geneticsPediatricsNephropathyColic hyperechogenicityAntenatalLysinuria-cystinurialysinuric protein intolerance

Outcome Measures

Primary Outcomes (1)

  • Postnatal outcome of fetuses

    Postnatal outcome of fetuses with hyperechogenic colon.

    day 1 (End of follow up)

Secondary Outcomes (2)

  • Rate of lysinuria/cystinuria

    day 1 (End of follow up)

  • Rate of dibasic protein intolerance

    day 1 (End of follow up)

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Foetuses with prenatal colic hyperechogenicity

You may qualify if:

  • Fetuses with prenatal colic hyperechogenicity
  • Between January 2011 and January 2021
  • Born without term limitation.

You may not qualify if:

  • Intestinal hyperechogenicity
  • polymalformative syndrome
  • Patients Age\<15 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

ColicKidney DiseasesLysinuric Protein Intolerance

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Florent FUCHS, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florent FUCHS, PhD

CONTACT

04 67 33 09 80f-fuchs@chu-montpellier.fr

Alexis RODRIGUEZ, resident

CONTACT

668591043alexis-rodriguez@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 30, 2021

Study Start

July 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

FR(1)