Turner Syndrome Prenatal Diagnosis Study

NCT ID: NCT01668251

Last Updated: 2012-08-20

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

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Turner Syndrome

Keywords

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Turner syndrome Diagnosis, prenatal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fetal ascertainment

Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound.

No interventions assigned to this group

Maternal ascertainment

Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

3 Months

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patricia Fechner

Associate Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Fechner, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Fechner, MD

Role: CONTACT

Phone: 206-987-5037

Email: [email protected]

Facility Contacts

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Patricia Fechner, M.D.

Role: primary

Sue Kearns, RN

Role: backup

References

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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. doi: 10.1542/peds.2003-1122-L.

Reference Type BACKGROUND
PMID: 15342833 (View on PubMed)

Other Identifiers

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TS Prenatal Study

Identifier Type: -

Identifier Source: org_study_id