Non Invasive Prenatal Testing of Down Syndrome (SAFE 21)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02127515|
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : March 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome||Procedure: Non Invasive Prenatal Testing Procedure: Invasive Prenatal Testing||Not Applicable|
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:
- Percentage of fetal loss in each group
- Percentage of invasive tests in each group (amniocentesis or chorionic villus sampling )
- Diagnostic performance of NIPT , in particular false positive and negative
- Percentage of results within 3 weeks and average time interval for results of NIPT
- Percentage of inconclusive results of DPANI
- Percentage of other anomalies discovered at invasive sampling
- Percentage of invasive samples taken despite normal NIPT (either because of later ultrasound anomaly or for maternal reinsurance)
- Association between maternal characteristics ( weight, height, parity , previous history , serum markers ... ) and the results of NIPT
- Cost analysis of NIPT in routine clinical practice
The study will include 2450 high risk women in order to be powered enough to detect a 1% reduction of miscarriages in the group undergoing NIPT instead of routine invasive prenatal diagnosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non Invasive Prenatal Testing of Down Syndrome From Maternal Blood Sample|
|Actual Study Start Date :||April 8, 2014|
|Actual Primary Completion Date :||November 7, 2016|
|Actual Study Completion Date :||November 7, 2016|
Experimental: Non Invasive Prenatal Testing
Procedure: Non Invasive Prenatal Testing
Active Comparator: Invasive Prenatal Testing
CVS or amniocentesis
Procedure: Invasive Prenatal Testing
- Number or miscarriages [ Time Frame: at birth ]
- 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
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): NCT02127515
|Hôpital Necker- Enfants Malades|
|Paris, France, 75015|
|Principal Investigator:||Laurent J Salomon, MD, PhD||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Michel VEKEMANS, MD, PhD||Assistance Publique - Hôpitaux de Paris|