Skip to main content
OpenTrials
Completed

NCT Number: NCT02424474

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trisomy 21, 18 and 13 Screening Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP, Antoine Béclère Hospital

Clamart, 92141, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic NIPT

Device

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

Biological

Other names: Usual screening

Primary outcomes

  1. 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

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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)

Acronym: DEPOSA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 23, 2015
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.