Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant woman

Singleton pregnancy

Pregnancy between 7 and 16 weeks of amenorrhea (WA)

Woman ≥ 18 years

Disqualifiers

None

Trial population

Pregnant women with a priori genetic risk

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Inclusion (Visit 1 - Week 7-16)

    Procedure/Surgery

    Extraction of cervico-vaginal sampling

  • Second semester of pregnancy (Visit 2 - Week 20-24)

    Diagnostic test

    Ultrasound examination (determination of chromosomal sex)

  • Third semester of pregnancy (Visit 3- Week 34)

    Diagnostic test

    Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Pregnant women3 interventions

Trial outcomes

Primary outcomes

1

Establish an ultra-early detection method

Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography

Time frame
Visit 2 (Week 20-24)

Secondary outcomes

1

Evaluate the ability of the method to provide a result in the context of a progressive pregnancy

* Time (minutes) elapsed between sampling and biological validation of the result * Number of trophoblast cells identified * Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex

Time frame
Visit 2 (Week 20-24)
2

Expected benefit of ultra-early cytogenetic information

Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women

Time frame
Visit 2 (Week 20-24)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.