Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong

Genetic Testing Clinical Trial

Official title:

Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742116
• Other study ID #: ECSFPA1.0
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: November 1, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Observational

Clinical Trial Summary

The objectives are to:

1. Assess patient's views and preferences in receiving expanded carrier screening

2. Perform qualitative study on post testing counselling on screen positive individuals and at risk couples

Description:

This study is to recruit 50 couples for Expanded carrier screening at Prepregnancy Checkup Clinic at the Family Planning Association.

Saliva swabs are collected from couples for Hereditary Disease DNA screening test by DrGene.

Blood samples are taken by venipuncture of women for Fragile X carrier screening by Prenatal Diagnostic Laboratory, Tsan Yuk Hospital.

A pre-test self-administered Questionnaire 1 will be administered to couples to assess their knowledge, views and preferences in receiving expanded carrier screening. This include collection of basic demographic information, answers to questions on basic principles of expanded carrier testing, reasons of having or declining the test, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level of the patient is assessed by state-trait anxiety inventory. Their willingness to pay for the test is also assessed.

The test results will be available to couples in 6 week's time. A post-test self-administered questionnaire 2 will be administered to couples on receiving the test results at the clinic. These include assessment of anxiety level, any decision regret, outcome of test and resulting action.

The couples with a screen positive result will be referred to Queen Mary Hospital for a joint counselling by clinical geneticist and gynaecologist. This counselling/consultation shall be audiotaped or videotaped. The interviews will be transcribed verbatim. The data will be explored for themes and issues identified.

Statistics Questionnaire survey data shall be entered into SPSS. Descriptive statistics will be used to compare responses and choices of participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ethnic Chinese couples who attend prepregnancy clinic

• Age 18 or above

Exclusion Criteria:

• Couples who cannot read or understand Chinese or English

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Genetic Testing

Intervention

Genetic:
• DNA screening before Pregnancy
Saliva/swab shall be collected from couple for Hereditary Disease DNA screening test. Blood sample shall be taken by venipuncture of women for Fragile X carrier screening A pre-test questionnaire will be conducted to assess subject's knowledge, views and preferences in receiving expanded carrier screening, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level, and their willingness to pay for the test. A post-test self-administered questionnaire shall be filled in by the patient on receiving the test results. Couples who receive a screen positive result shall be subsequently referred to Queen Mary Hospital for joint counselling by clinical geneticist and gynaecologist. This consultation shall be audiotaped or videotaped.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The Family Planning Association of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient acceptance and literacy of expanded carrier screening	Factors affecting the choice of expanded carrier screening in the prepregnancy and subfertility patients Identify counselling issues when expanded carrier screening is offered in the local setting	6 weeks	No
Secondary	Patient acceptance and literacy of expanded carrier screening	cost, false positives, workload generated from offering expanded carrier screening	6 months	No