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

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ClinicalTrials.gov Identifier: NCT02742116
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
The Family Planning Association of Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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

Condition or disease Intervention/treatment
Genetic Testing Genetic: DNA screening before Pregnancy

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.


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient acceptance and literacy of expanded carrier screening [ Time Frame: 6 months ]
    cost, false positives, workload generated from offering expanded carrier screening


Biospecimen Retention:   Samples With DNA

Saliva/swab shall be collected from patient/couple for Hereditary Disease DNA screening test by DrGene.

Blood sample shall be taken by venipuncture of women for Fragile X carrier screening by Prenatal Diagnostic Laboratory, Tsan Yuk Hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both female and male Chinese participants are being studied
Criteria

Inclusion Criteria:

  • Ethnic Chinese couples who attend prepregnancy clinic
  • Age 18 or above

Exclusion Criteria:

  • Couples who cannot read or understand Chinese or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742116


Sponsors and Collaborators
The University of Hong Kong
The Family Planning Association of Hong Kong
Investigators
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Principal Investigator: Grace CY Wong, MD The Family Planning Association of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02742116     History of Changes
Other Study ID Numbers: ECSFPA1.0
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
Expanded carrier screening