Clinical Trial: Non Invasive Prenatal Testing of Down Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Non Invasive Prenatal Testing of Down Syndrome From Maternal Blood Sample

Brief Summary: This is a randomized controlled trial in women at risk following combined prenatal screening for Down Syndrome. Women will be asked about their preferences between NIPT and routine prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between NIPT and standard invasive prenatal diagnosis.

Detailed Summary:

This is a randomized controlled trial in women at risk following combined prenatal screening for Down Syndrome. Women will be asked about their preferences between NIPT and routine prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between NIPT and standard invasive prenatal diagnosis.

The general objectives are :

  • Promote the rapid and large implementation of Non Invasive Prenatal Testing (NIPT) for Down syndrome.
  • Improve the management of women at risk after combined first trimester screening and reduce the number of invasive procedures and induced miscarriages .
  • Evaluate NIPT medically (in reducing the rate of invasive sampling and related complications, diagnostic performance and feasibility and acceptability in routine practice) and based on cost-analysis in comparison with standard invasive prenatal diagnosis currently proposed .
  • Clarify the conditions of implementation and dissemination of NIPT in the overall organization of prenatal screening for trisomy 21 (and provide data to later adjust or not the combination of tests and thresholds).

Promote the organization as networks of professionals involved in prenatal screening for trisomy 21 in order to allow the emergence of a national system of collection of outcomes to improve the quality of practices

The main judgement criteria are:

  • Main:

    - Percentage of fetal loss in each group


  • Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Number or miscarriages [ Time Frame: at birth ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Number or invasive tests [ Time Frame: at birth ]
    • false positive and negative rates of NIPT [ Time Frame: At birth ]
    • Dedicated questionnaire for patients [ Time Frame: day 5 ]
    • Cost of invasive tests and NIPT in euros [ Time Frame: at birth ]
      measure in euros


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: April 2, 2014
    Date Started: April 2014
    Date Completion: December 2016
    Last Updated: November 11, 2015
    Last Verified: November 2015