NCT04737083

Brief Summary

In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

15 days

First QC Date

January 25, 2021

Last Update Submit

January 31, 2021

Conditions

ClubfootPrenatal Disorder

Outcome Measures

Primary Outcomes (1)

  • rate of abnormal CGH-array in the population

    9 months

Secondary Outcomes (1)

  • type of abnormalities in CGH-array study

    9 months

Study Arms (1)

clubfoot fetuses

Genetic: CGH array

Interventions

CGH arrayGENETIC

a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening

clubfoot fetuses

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.

You may qualify if:

  • pregnant women
  • fetus with isolated bilateral clubfoot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor (MD)

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 3, 2021

Study Start

January 31, 2021

Primary Completion

February 15, 2021

Study Completion

November 30, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01