Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes EquinovarusNCT05638490
Study on Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus
An observational study of Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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:
Who may be able to join
- 1）Single pregnant women 2) "congenital talipes equinovarus" suggested by ultrasound
Who cannot join
- Twin or multiple pregnancies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Drum Tower hospital
Nanjing, Jiangsu, 210008
xiangyu zhu, doctor, 13951005854, xiangyuzhu82@sina.com
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic testing results of congenital talipes equinovarus
chromosomal microarray analysis or whole exome screening to find genetic abnormalities of congenital talipes equinovarus
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start3 Aug 2022
- Primary completionAug 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes EquinovarusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xiangyu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638490
- Sponsor's protocol ID
- CTE-V1.0
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Talipes Equinovarus Prenatal Diagnosis and Closed Loop Management System Single Center Observational Prospective Study Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT05638490
- Acronym / sponsor ID
- CTE-V1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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:
Key inclusion criteria (1 listed)
- 1）Single pregnant women 2) "congenital talipes equinovarus" suggested by ultrasound
Key exclusion criteria (1 listed)
- Twin or multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Genetic testing results of congenital talipes equinovarus
Time frame: 2 years
chromosomal microarray analysis or whole exome screening to find genetic abnormalities of congenital talipes equinovarus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic testing results of congenital talipes equinovarus (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.