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

November 1, 2016 updated by: The University of Hong Kong

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both female and male Chinese participants are being studied

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptance and literacy of expanded carrier screening
Time Frame: 6 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptance and literacy of expanded carrier screening
Time Frame: 6 months
cost, false positives, workload generated from offering expanded carrier screening
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The Family Planning Association of Hong Kong

Investigators

  • Principal Investigator: Grace CY Wong, MD, The Family Planning Association of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ECSFPA1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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