NCT03582111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

7.8 years

First QC Date

June 27, 2018

Last Update Submit

July 10, 2018

Conditions

Cleft Lip and Palate

Keywords

UltrasoundPregnancyDiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Study the cleft palate diagnosis when cleft lip is present

    At birth

Study Arms (1)

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

Study of medical recordsOTHER

Study of medical records

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

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Diagnosis not confirmed at birth and ultrasound picture not interpretable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cleft LipDisease

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cyrielle LEFEBVRE, Midwife

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 10, 2018

Study Start

February 1, 2009

Primary Completion

December 1, 2016

Study Completion

May 1, 2018

Last Updated

July 11, 2018

Record last verified: 2018-06

Locations

FR(1)