Study on Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus

Congenital Talipes Equinovarus Prenatal Diagnosis and Closed Loop Management System Single Center Observational Prospective Study Clinical Study Protocol

The study intends to establish a closed-loop management from prenatal to postnatal through prospective cohort, and comprehensively utilize ultrasound and MRI technology to establish a prenatal diagnosis and evaluation system for congenital talipes equinovarus. On the basis of existing genetic testing, further use of whole-exome sequencing and other genomic methods to explore possible pathogenic genes and loci, and clarify the pathogenic mechanism of congenital talipes equinovarus. Therefore, congenital talipes equinovarus can improve its diagnosis and treatment capacity, reduce the disability rate related to congenital talipes equinovarus, and prevent it well.

Study Overview

• Status: Recruiting
• Conditions: Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Drum Tower Hospital
      • Contact: xiangyu zhu, doctor; Phone Number: 13951005854; Email: xiangyuzhu82@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Single pregnant women with "congenital talipes equinovarus" suggested by ultrasound in our hospital; Voluntary prenatal diagnosis; Those who voluntarily participate in this subject and can comply with the requirements of doctors; Voluntary interview with interviewees:

Description

Inclusion Criteria:

1）Single pregnant women 2) "congenital talipes equinovarus" suggested by ultrasound

Exclusion Criteria:

Twin or multiple pregnancies

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic testing results of congenital talipes equinovarus	chromosomal microarray analysis or whole exome screening to find genetic abnormalities of congenital talipes equinovarus	2 years

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Disease; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: CTE-V1.0

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