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

August 11, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

933

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • AP-HP, Antoine Béclère Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genetic NIPT and regular serum screening
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
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
Other Names:
  • Usual screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Between the 11th and the 13th week of amenorrhea

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Between the 11th and the 13th week of amenorrhea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Alexandra Benachi, MD, PhDi, AP-HP, Antoine Béclère Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P141001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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