CGH Array in Bilateral Clubfoot

January 31, 2021 updated by: Matthieu DAP, Central Hospital, Nancy, France

Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • pregnant women
  • fetus with isolated bilateral clubfoot

Exclusion Criteria:

  • no

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of abnormal CGH-array in the population
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
type of abnormalities in CGH-array study
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (ANTICIPATED)

January 31, 2021

Primary Completion (ANTICIPATED)

February 15, 2021

Study Completion (ANTICIPATED)

November 30, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (ACTUAL)

February 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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