NCT02586428

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

September 8, 2015

Last Update Submit

October 13, 2016

Conditions

Genetic Counseling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • will measure patients' reasons for electing or not electing testing

    over the next 6 months

  • Measure if patients' understand the different testing options.

    over next 6 months

Interventions

what patients elect noninvasive prenatal testing (NIPT)OTHER

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

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who have abnormal ultrasound findings, advance maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. These patients will be scheduled ahead of time with the genetic counseling.

You may qualify if:

  • high risk pregnant women seen for genetic counseling

You may not qualify if:

  • low risk
  • not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Hospital

St Louis, Missouri, 63117, United States

Location

Study Officials

  • Gary Fruhman, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 8, 2015

First Posted

October 26, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

US(1)