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

Trisomy 21, 18 and 13 Screening Clinical Trial

— DEPOSA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424474
• Other study ID #: P141001
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: August 11, 2017
• Start date: June 2015
• Est. completion date: February 14, 2017

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: February 14, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 21, 18 and 13 Screening

Intervention

Device:
• Genetic NIPT
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.

Biological:
• Regular serum screening

Locations

Country	Name	City	State
France	AP-HP, Antoine Béclère Hospital	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening	positive ad negative predictive values of NIPT in the two populations of woman with and without IVF.	Between the 11th and the 13th week of amenorrhea
Secondary	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