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

Not Applicable

Completed

• Conditions: Trisomy 21, 18 and 13 Screening
• Interventions: Device: Genetic NIPT; Biological: Regular serum screening

• Registration Number: NCT02424474
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Description

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.

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-23
• Study Start: 2015-06
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2017-02-14
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 933

Inclusion Criteria

• Age >18
• Singleton pregnancy
• Having a spontaneous pregnancy or obtained by AMP ,
• Having chosen to carry out a screening of the T21 to the first or second trimester of pregnancy ,
• Gestational age >=10 weeks of amenorrhea
• Consenting to invasive prenatal diagnosis,
• Having health insurance,
• Having signed the informed consent

Exclusion Criteria

• The Patients whose fetus has an abnormality on the first trimester ultrasound including nuchal translucency > 3.5mm ,
• Participant to another biomedical research.
• Pregnancy twins including the presence of a twin vanishing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genetic NIPT and regular serum screening	Genetic NIPT	All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
Genetic NIPT and regular serum screening	Regular serum screening	All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.

Primary Outcome Measures

Name	Time	Method
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	Between the 11th and the 13th week of amenorrhea

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening	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	Between the 11th and the 13th week of amenorrhea

Trial Locations

Locations (1)

AP-HP, Antoine Béclère Hospital; 🇫🇷 Clamart, France