Genetic CounselingINVASIVENCT04119349
Influence of Prenatal Counseling in Invasive Testing
A study testing Extra counseling in people with Genetic Counseling and Prenatal Diagnosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genetic Counseling, Prenatal Diagnosis
- What is being tested?
- Extra counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2019to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Prenatal Counseling on the Attitudes and Preferences Towards Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy
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.
Read the detailed description
Study design:
This is a randomized open-label controlled trial evaluating the impact of an extra 15-minute prenatal counseling before the first trimester combined screening test for Down's syndrome, on the women's attitudes and preferences towards having invasive testing as the first-line option for the screening of chromosomal abnormalities.
Data will be collected by the study-site manager and stored in an electronic data-capture database. The coordinator of the study and the statistician will witness the accuracy of the data at the beginning, middle, and end of the study (on-site audit). Data will be captured in a paper form basis and then captured into the electronic database.
Sample size calculation has been made using an independent two-sample proportions likelihood-ratio test. The investigators expect a 10% of women willing to have an invasive procedure as a first-line test for aneuploidies in the control group, and a 25% difference to those in the experimental group that is given an extra 15-minute prenatal counseling, this yields a sample of 42 women per arm with a total of 84 subjects using a Type I error of 0.0501 and a power of 80% by a two-sided test.
Randomization and intervention
Questionnaire The questionnaire consists of twenty-one questions assessing the knowledge, preferences, and attitude towards prenatal testing in the first trimester of pregnancy. The questionnaire will be divided into two parts. The first fourteen questions consist of demographic characteristics and obstetrics history, such as age, ethnicity, study level, marital status, religion, salary, employment, parity, previous miscarriages, previous terminations of pregnancy, previous congenital defects, pregnancy search time in months, type of conception, and who had provided any type of previous information about prenatal screening/testing. Women will be asked to select only one option for each question. All questions will have the possibility to answer as "Prefer not to answer". The second part of the questionnaire will assess the preferences and attitudes towards prenatal testing; women will be asked to choose only one option for each question. The following questions will be included in the second part of the questionnaire: What influences the participants the most about prenatal testing? Who influenced the participants the most about prenatal testing? Would the participants like to choose their prenatal test? Which prenatal test would the participants choose? What is the participants' opinion about termination? All questions include an "I don't know answer". The two final questions will ask the following, "What information regarding the results of prenatal testing is more important for the participants?" and "What is most important for the participants about prenatal testing?". Women will be asked to score the first question from 1 to 5, meaning 1 the least important and 5 the most important, and from 1 to 6 in the same manner for the second question. These two questions will be assessed as means, where the question with the highest mean represents what is most important for the patient.
The analysis will be conducted by intention-to-treat. Missing data for the main outcome will be handled by complete-data analysis because women without an answer on the main outcome will be excluded. All analyses will be divided by groups (control vs experimental group). Continuous data will be assessed for normality using the Kolmogorov-Smirnoff test. Normally distributed variables will be compared using t-test and expressed as mean and standard deviation (SD), while not normally distributed variables will be analyzed using the Mann-Whitney-U test and expressed as medians and interquartile range (IQR). Quantitative variables will be compared using X2 test and expressed as numbers (n) and proportions (%). For the main outcome, preferences for prenatal testing among groups will be analyzed using absolute risk increase defined as the incidence of the outcome in the experimental group minus the incidence in the control group. The absolute risk increase will be depicted in a forest plot. A multivariate logistic regression will be performed to determine the Odds for choosing invasive testing adjusting by demographic characteristics and previous counseling. Data will be analyzed using STATA v.15.3 for Mac (Texas College Station) and GraphPad Prism version 8.1.2 for Mac, GraphPad Software, San Diego, California USA, www.graphpad.com.
- Conditions
- Genetic Counseling, Prenatal Diagnosis
- Being tested
- Extra counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra counselingBehavioural
Participants will be given an extra 15-minute prenatal counseling before their first-trimester scan. The extra counseling, which is the intervention in the experimental group, consists of an explanation of all screening techniques for chromosomal abnormalities, including the first trimester combined test, cfDNA testing, invasive testing, and no screening at all.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Women are given extra 15-minute counseling on the pros and cons of all different methods for prenatal testing including no testing at all Receives: Behavioral: Extra counseling |
| Standard care | No intervention | Women receiving standard care by means of counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic CounselingStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized using an interactive Web-response system assigning patients in a 1:1 ratio to receive the extra counseling before first trimester assessment (intervention group) or nothing (control group). The allocation will be performed by the study manager. The maternal-fetal medicine specialist will be in charge of the participant's enrolment and will also perform the intervention to the corresponding randomized group. This is an open-label study which means that the specialist and women will be aware of the allocation and intervention every time.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raigam Jafet Martinez Portilla, Hospital Clinic of Barcelona
- Investigators
- Raigam J MartinezcPortilla, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119349
- Sponsor's protocol ID
- IRN2019/03/0001
- Acronym
- INVASIVE
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paz Y Mino F, Martinez-Portilla RJ, Pauta M, Borrell A. A Randomized Controlled Trial on the Influence of Prenatal Counseling on the Attitudes and Preferences Toward Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy (INVASIVE). Front Genet. 2020 Nov 9;11:561283. doi: 10.3389/fgene.2020.561283. eCollection 2020.
PubMed 33240315
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prenatal Counseling on the Attitudes and Preferences Towards Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT04119349
- Acronym / sponsor ID
- INVASIVE / IRN2019/03/0001
- Conditions
- Genetic Counseling, Prenatal Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:
This is a randomized open-label controlled trial evaluating the impact of an extra 15-minute prenatal counseling before the first trimester combined screening test for Down's syndrome, on the women's attitudes and preferences towards having invasive testing as the first-line option for the screening of chromosomal abnormalities.
Data will be collected by the study-site manager and stored in an electronic data-capture database. The coordinator of the study and the statistician will witness the accuracy of the data at the beginning, middle, and end of the study (on-site audit). Data will be captured in a paper form basis and then captured into the electronic database.
Sample size calculation has been made using an independent two-sample proportions likelihood-ratio test. The investigators expect a 10% of women willing to have an invasive procedure as a first-line test for aneuploidies in the control group, and a 25% difference to those in the experimental group that is given an extra 15-minute prenatal counseling, this yields a sample of 42 women per arm with a total of 84 subjects using a Type I error of 0.0501 and a power of 80% by a two-sided test.
Randomization and intervention
Questionnaire The questionnaire consists of twenty-one questions assessing the knowledge, preferences, and attitude towards prenatal testing in the first trimester of pregnancy. The questionnaire will be divided into two parts. The first fourteen questions consist of demographic characteristics and obstetrics history, such as age, ethnicity, study level, marital status, religion, salary, employment, parity, previous miscarriages, previous terminations of pregnancy, previous congenital defects, pregnancy search time in months, type of conception, and who had provided any type of previous information about prenatal screening/testing. Women will be asked to select only one option for each question. All questions will have the possibility to answer as "Prefer not to answer". The second part of the questionnaire will assess the preferences and attitudes towards prenatal testing; women will be asked to choose only one option for each question. The following questions will be included in the second part of the questionnaire: What influences the participants the most about prenatal testing? Who influenced the participants the most about prenatal testing? Would the participants like to choose their prenatal test? Which prenatal test would the participants choose? What is the participants' opinion about termination? All questions include an "I don't know answer". The two final questions will ask the following, "What information regarding the results of prenatal testing is more important for the participants?" and "What is most important for the participants about prenatal testing?". Women will be asked to score the first question from 1 to 5, meaning 1 the least important and 5 the most important, and from 1 to 6 in the same manner for the second question. These two questions will be assessed as means, where the question with the highest mean represents what is most important for the patient.
The analysis will be conducted by intention-to-treat. Missing data for the main outcome will be handled by complete-data analysis because women without an answer on the main outcome will be excluded. All analyses will be divided by groups (control vs experimental group). Continuous data will be assessed for normality using the Kolmogorov-Smirnoff test. Normally distributed variables will be compared using t-test and expressed as mean and standard deviation (SD), while not normally distributed variables will be analyzed using the Mann-Whitney-U test and expressed as medians and interquartile range (IQR). Quantitative variables will be compared using X2 test and expressed as numbers (n) and proportions (%). For the main outcome, preferences for prenatal testing among groups will be analyzed using absolute risk increase defined as the incidence of the outcome in the experimental group minus the incidence in the control group. The absolute risk increase will be depicted in a forest plot. A multivariate logistic regression will be performed to determine the Odds for choosing invasive testing adjusting by demographic characteristics and previous counseling. Data will be analyzed using STATA v.15.3 for Mac (Texas College Station) and GraphPad Prism version 8.1.2 for Mac, GraphPad Software, San Diego, California USA, www.graphpad.com.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized using an interactive Web-response system assigning patients in a 1:1 ratio to receive the extra counseling before first trimester assessment (intervention group) or nothing (control group). The allocation will be performed by the study manager. The maternal-fetal medicine specialist will be in charge of the participant's enrolment and will also perform the intervention to the corresponding randomized group. This is an open-label study which means that the specialist and women will be aware of the allocation and intervention every time.
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: Extra counselingWomen are given extra 15-minute counseling on the pros and cons of all different methods for prenatal testing including no testing at all |
| Standard care | No intervention | –Women receiving standard care by means of counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra counselingParticipants will be given an extra 15-minute prenatal counseling before their first-trimester scan. The extra counseling, which is the intervention in the experimental group, consists of an explanation of all screening techniques for chromosomal abnormalities, including the first trimester combined test, cfDNA testing, invasive testing, and no screening at all. | Behavioural | Counseling |
Primary outcome
Preference for an invasive testing
Time frame: Through study completion, an average of 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 33240315Paz Y Mino F, Martinez-Portilla RJ, Pauta M, Borrell A. A Randomized Controlled Trial on the Influence of Prenatal Counseling on the Attitudes and Preferences Toward Invasive Prenatal Testing Among Women in Their First Trimester of Pregnancy (INVASIVE). Front Genet. 2020 Nov 9;11:561283. doi: 10.3389/fgene.2020.561283. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raigam J MartinezcPortilla, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra counseling in people with Genetic Counseling and Prenatal Diagnosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for an invasive testing (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.