Noninvasive Prenatal Testing

Genetic Counseling Clinical Trial

Official title:

Decision-Making in Patients Regarding Noninvasive Prenatal Testing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02586428
• Other study ID #: 25878
• Status: Terminated
• Phase: N/A
• First received: September 8, 2015
• Last updated: October 13, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. The investigators will emphasize that their answers will remain anonymous throughout the entire process, and that their participation is strictly voluntary. The patient will be provided with a survey and asked to complete this before their genetic counseling session and after.The survey will be returned to the genetic counselor and placed in a locked drawer. Information will also be collected from the medical record including age, pregnancy history and the reason for the visit.

Description:

Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.

The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.

Patients will not be contacted for research purposes after the survey has been completed.

After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria:

• high risk pregnant women seen for genetic counseling

Exclusion Criteria:

• low risk

• not pregnant

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Genetic Counseling

Intervention

Other:
• what patients elect noninvasive prenatal testing (NIPT)
what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling.

Locations

Country	Name	City	State
United States	St. Mary's Hospital	St. Louis,	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling	percentages of patient's choices	over the next 6 months	No
Secondary	will measure patients' reasons for electing or not electing testing	Reasons for not electing to have testing	over the next 6 months	No
Secondary	Measure if patients' understand the different testing options.	Are they able to give explanation of testing	over next 6 months	No