Pregnancy Clinical Trial
— DEPIST21Official title:
Assessment of Women's Insight and Understanding of Non-invasive Prenatal Testing (NIPT) During Their First Trimester Ultrasound
NCT number | NCT03549286 |
Other study ID # | PZ18071 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | February 2, 2019 |
Verified date | May 2018 |
Source | CHU de Reims |
Contact | Laura DUMINIL |
Phone | 03 26 78 76 49 |
lduminil[@]chu-reims.fr | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Down's syndrome is the leading cause for mental retardation in France. Screening for this
chromosomal abnormality is systematically proposed during pregnancy.
Until April 2017, prenatal screening for Down's syndrome was based on a combined screening
test which included fetal ultrasound markers and maternal serum hormone levels prescribed
after the first trimester ultrasound. Depending on this screening result, women that
presented a higher risk of ill fetuses could benefit from invasive procedures (amniocentesis
or trophoblastic biopsy) in order to have a karyotype and make certain diagnosis. The latter
procedure involved risks of complications such as miscarriages, infections and water break.
A new screening procedure is available since 2017. It relies on detecting an extra 21
chromosome in cell-free DNA by a simple maternal blood test, called noninvasive prenatal
screening (NIPT). This screening test is highly efficient with a detection of 99 % of fetuses
affected by Down's syndrome and therefore enables practitioners to avoid 95% of invasive
samples. NIPT implies to proceed to a diagnosis test as well (amniocentesis and trophoblastic
biopsy) to obtain karyotype and confirm diagnosis.
Few studies show a concerning level of Down's syndrome screening general strategy. There is a
clear lack of understanding of the information provided by the health professional during the
first trimester ultrasound. Women report feeling uninformed and confused about French
screening strategy. Nevertheless, high quality insight is essential to ensure validity of
women's consent to perform Down's syndrome screening and quality of provided health care.
Since introduction of NIPT, no study has been carried out to assess women's prior knowledge
to NIPT for Down's syndrome. Main objective of the study is therefore to evaluate women's
information and understanding of Down's syndrome screening using NIPT. Secondary objectives
stand in collecting modalities of the provided information by the doctor performing the first
ultrasound and assess patient's satisfaction regarding this information.
Understanding of this new screening strategy by pregnant women is a key issue in decision
making. This observational study is intended for all pregnant patients from 11 to 17 + 6 WA
(weeks of amenorrhea) expecting a single baby, consulting in the obstetrics and gynecology
department of the University Hospital of Reims for their 1st trimester ultrasound.
Participation to the study will not change patient's medical care. The doctor who carries out
the ultrasound will not be aware of the patient's participation in the study. Concordant
results with literature using the experience of what was done for Down's syndrome screening
prior to NIPT are expected. Communication on this matter to the lay public is scarce. Level
of knowledge regarding NIPT before the consultation is expected to be insufficient. The
absolute necessity of upstream information (brochure provided by secretaries, information
disclosed throughout the three month pregnancy consultation, booklet delivered with initial
documents ....) to enhance patient's comprehension and satisfaction will be highlighted.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2, 2019 |
Est. primary completion date | November 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Major - pregnancy between 11 and 17 +6 SA - who consults in the gynecology department of the University Hospital of Reims for the realization of the first trimester ultrasound - have accepted to participate in the study Exclusion Criteria: - Minor - presenting a twin pregnancy (because in this indication, the serum markers are not validated nor the NIPT) - not French speaker - having a personal or family history of Down's syndrome - Patients for whom the measurement of craniocaudal length during the first trimester ultrasound estimates the pregnancy before 11SA or after 17 + 6 SA - Patients for whom ectopic pregnancy is discovered during first trimester ultrasound |
Country | Name | City | State |
---|---|---|---|
France | Damien JOLLY | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | knowledge about Down's syndrome screening | sum of the correct responses in the 10 items questionnaire assessing knowledge about Down's syndrome screening | Day 0 |
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