Turner Syndrome Prenatal Diagnosis Study

Turner Syndrome Clinical Trial

Official title:

National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01668251
• Other study ID #: TS Prenatal Study
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2011
• Last updated: August 14, 2012
• Start date: January 2006
• Est. completion date: January 2017

Study information

• Verified date: August 2012
• Source: Seattle Children's Hospital
• Contact: Patricia Fechner, MD
• Phone: 206-987-5037
• Email: patricia.fechner[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.

Description:

This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age.

No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Turner syndrome diagnosed prenatally

• Less than 4 months of age at time of enrollment

Exclusion Criteria:

• Turner syndrome diagnosed postnatally

• Older than 4 months of age at time of enrollment

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of signs of Turner syndrome	Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment	three to six years	No
Secondary	Growth	Do girls with Turner syndrome ascertained by fetal ascertainment grow differently than girls ascertained by maternal ascertainment.	three to six years	No