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RecruitingNCT05638490Updated Dec 6, 2022

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

An observational study in Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 3 months later.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

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

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03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's planned enrollment of 100 is above the median of 55 across 27 observational studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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:

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Twin or multiple pregnancies

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Genetic testing results of congenital talipes equinovarus

    chromosomal microarray analysis or whole exome screening to find genetic abnormalities of congenital talipes equinovarus

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Drum Tower hospital
    Nanjing, Jiangsu 210008, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2022 (actual). Primary completion is estimated for Aug 2024, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2022
First posted
Dec 6, 2022
StartActual
Aug 3, 2022
Primary completionEst.
Aug 2024
CompletionEst.
Dec 2025
Last update
Dec 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05638490
Responsible party
Zhu Xiangyu (Deputy director xiangyu zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Dec 6, 2022
Start date
Aug 3, 2022
Primary completion
Aug 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Dec 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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