Ultrasound Diagnosis of Cleft Lip and Palate | NCT03582111

Studies
Ultrasound Diagnosis of Cleft Lip and Palate

NCT03582111

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jul 11, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cleft Lip and Palate

Interventions

Study of medical records

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009Actual

Primary Completion Date

Dec 2016Actual

Completion Date

May 2018Actual

First Submitted Date

Jun 27, 2018

First Submission Date that Met QC Criteria

Jun 27, 2018

First Posted Date

Jul 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2018

Last Update Posted Date

Jul 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women who have a foetus with a cleft lip/palate		Pregnant women who have a foetus with a cleft lip/palate	Other: Study of medical records

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study of medical records	Other	Study of medical records	Pregnant women who have a foetus with a cleft lip/palate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the prenatal and postnatal diagnosis of cleft lip and palate	Compare the prenatal and postnatal diagnosis of cleft lip and palate	At birth

Secondary Outcomes

Measure	Description	Time Frame
Study the cleft palate diagnosis when cleft lip is present	Study the cleft palate diagnosis when cleft lip is present	At birth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

46 Years

Standard Ages

Adult

Study Population

Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier hospital (Arnaud de Villeneuve) between February 2009 and December 2016.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cyrielle LEFEBVRE, Midwife	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip
D004194	Disease

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided