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CGH Array in Bilateral Clubfoot

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ClinicalTrials.gov Identifier: NCT04737083
Recruitment Status : Not yet recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Matthieu DAP, Central Hospital, Nancy, France

Study Description
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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.

Condition or disease Intervention/treatment
Clubfoot Prenatal Disorder Genetic: CGH array

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prenatal Testing

Groups and Cohorts
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Group/Cohort Intervention/treatment
clubfoot fetuses Genetic: CGH array
a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening


Outcome Measures
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Primary Outcome Measures :
  1. rate of abnormal CGH-array in the population [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. type of abnormalities in CGH-array study [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.
Criteria

Inclusion Criteria:

  • pregnant women
  • fetus with isolated bilateral clubfoot

Exclusion Criteria:

  • no
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Matthieu DAP, medical doctor (MD), Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04737083    
Other Study ID Numbers: 2021PI006
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
 Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities