Overview

This trial is active, not recruiting.

Condition trisomy 21, 18 and 13 screening
Treatments genetic nipt, regular serum screening
Sponsor Assistance Publique - Hôpitaux de Paris
Start date June 2015
End date September 2016
Trial size 933 participants
Trial identifier NCT02424474, P141001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
genetic nipt
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
regular serum screening Usual screening

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Alexandra Benachi, MD, PhDi
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.