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Assessment of Women's Insight and Understanding of Down's Syndrome Screening by Non-invasive Prenatal Testing (NIPT) During Their First Ultrasound (DEPIST21)

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ClinicalTrials.gov Identifier: NCT03549286
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

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.


Condition or disease Intervention/treatment
Pregnancy Other: Questionnaire passation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Women's Insight and Understanding of Non-invasive Prenatal Testing (NIPT) During Their First Trimester Ultrasound
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : November 2, 2018
Estimated Study Completion Date : February 2, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
pregnant women in the first trimester ultrasound consultation
Participation in the study will be offered to all pregnant patients, presenting for their first trimester ultrasound consultation in the obstetrics and gynecology department of the University Hospital of Reims. The study includes the consultations of all the certified doctors of the Maternity Department of the Reims University Hospital carrying out the first trimester ultrasounds. It will concern all the ranges of consultation regardless of the doctor who performs the consultation.
Other: Questionnaire passation
Questionnaires assessing general knowledge about Down's syndrome screening, specific knowledge of NIPT for Down's syndrome and patient's satisfaction about provided information.




Primary Outcome Measures :
  1. knowledge about Down's syndrome screening [ Time Frame: Day 0 ]
    sum of the correct responses in the 10 items questionnaire assessing knowledge about Down's syndrome screening



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All pregnant patients, presenting for their first trimester ultrasound consultation in the obstetrics and gynecology department of the University Hospital of Reims.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549286


Contacts
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Contact: Laura DUMINIL 03 26 78 76 49 ext 0033 lduminil@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Laura DUMINIL    03 26 78 76 49 ext 0033    lduminil@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03549286     History of Changes
Other Study ID Numbers: PZ18071
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Pregnancy
Down's syndrome
non invasive prenatal testing
Additional relevant MeSH terms:
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Down Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn