Ultrasound Diagnosis of Cleft Lip and Palate

NCT ID: NCT03582111

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.

The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cleft Lip and Palate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women who have a foetus with a cleft lip/palate

Pregnant women who have a foetus with a cleft lip/palate

Study of medical records

Intervention Type OTHER

Study of medical records

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Study of medical records

Study of medical records

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age over 18
* Prenatal ultrasound diagnosis of cleft palate/lip.
* Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy

Exclusion Criteria

\- Diagnosis not confirmed at birth and ultrasound picture not interpretable
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cyrielle LEFEBVRE, Midwife

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL18_0284

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Ultrafast Ultrasound Imaging
NCT07299721 NOT_YET_RECRUITING