Genetic Counseling Clinical Trial
— INVASIVEOfficial title:
Influence of Prenatal Counseling on the Attitudes and Preferences Towards Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy
Verified date | November 2019 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is well established that screening for Down syndrome should be offered in the first
trimester to each pregnant woman. The most common screening method is nowadays the first
trimester combined test which consists of a Bayesian analysis of the a priori risk of
maternal age for Down's syndrome, and the posterior risk combining serum biomarkers such as
beta fraction of the human chorionic gonadotropin (β-hCG), pregnancy-associated plasma
protein-A (PAPP-A), and nuchal translucency measurement. Women at high risk for trisomy 21 or
18 using this combined test are eligible for chorionic villous sampling or amniocentesis for
a final diagnosis. In recent years there has been a huge advance in prenatal screening for
Down's syndrome with the advent of cell free DNA testing with higher sensitivity and
specificity than the combined test, in which a positive result must be also confirmed by an
invasive diagnostic procedure. But as the range of options broadens, also the need for health
education to allow women to have an adequately informed decision process on which prenatal
test better suits their needs. In multicultural cities, this has become especially important
to integrate patient's values and expectations to an evidence-based decision regarding
prenatal testing. There is high-quality evidence demonstrating that aversion to risk of fetal
loss related to an invasive test may come from incomplete information, shaping the attitude
towards which test to choose from the mother's point of view. And the disbelief that by
taking cfDNA testing the risk of miscarriage would be reduced.
Many information is available about preferences and attitudes in prenatal testing from
Northern European studies, but scarce information is available from Southern Europe, where
the amniocentesis rate in the nineties was as high as 40% of the urban pregnant population.
The investigators hypothesize that when enough information is given before the initial
screening, women will overcome aversion to invasive testing and will be more likely to choose
this method as their first choice when compared to women having routine care.
Status | Completed |
Enrollment | 75 |
Est. completion date | November 11, 2019 |
Est. primary completion date | November 11, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - any pregnant woman attending the first trimester combined screening test for chromosomal abnormalities - Singleton or twin pregnancies - Between 11+0 and 13+6 weeks' gestation Exclusion Criteria: - women not willing to participate in the study - women without an answer in the question regarding which prenatal test would they choose (main outcome) - women with no sufficient knowledge of Spanish or Catalan to be able to read and understand the questionnaire |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preference for an invasive testing | The primary outcome of the study is the desire to choose an invasive diagnostic testing as the first option of screening for chromosomal abnormalities. This will be measured in the questionnaire by asking the question: which prenatal test would you choose if given the opportunity? Women will be asked to choose only one answer between first trimester combined test, cell-free DNA, invasive testing in a yes/no format. The main outcome will be analized as the absolute risk increase along with tis 95% confidence interval. |
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