Clinical Trial: T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Fetal Aneuploidies Screening (21,18 and 13) by Cell Free Fetal DNA Analysis. Pilot Study in Low Risk Population and Pregnant Women After in Vitro Fertilisation (IFV)

Brief Summary: The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.

Detailed Summary: All pregnant women in 9 institutions in France will be offer both regular first trimester screening for trisomy 21 (T21) and cell free DNA non invasive (NI) screening test at the same time. Specificity and the positive and negative predictive values of the NI test will be analysed. The population will be divided in women who did and did not get pregnant after an In vitro fertilisation (IVF) procedure.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening [ Time Frame: Between the 11th and the 13th week of amenorrhea ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening [ Time Frame: Between the 11th and the 13th week of amenorrhea ]
    positive ad negative predictive values of NIPT in the two populations of woman with and without IVF.
  • Diagnostic performance measured by negative predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening [ Time Frame: Between the 11th and the 13th week of amenorrhea ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 8, 2015
Date Started: June 2015
Date Completion: November 2016
Last Updated: October 26, 2016
Last Verified: September 2016