Influence of Prenatal Counseling in Invasive Testing

NCT04119349 | Completed

• 1 other identifier: IRN2019/03/0001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Genetic Counseling; Prenatal Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 month

Study Arms (2)

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

Behavioral: Extra counseling

Standard care

NO INTERVENTION

Women receiving standard care by means of counseling

Interventions

Extra counseling BEHAVIORAL

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.

Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08028, Spain

Location

Related Publications (1)

• 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.

  PMID: 33240315 DERIVED

Study Officials

• Raigam J MartinezcPortilla, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: October 10, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)