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)

Fernanda Paz Y Miño, Raigam Jafet Martinez-Portilla, Montse Pauta, Antoni Borrell, Fernanda Paz Y Miño, Raigam Jafet Martinez-Portilla, Montse Pauta, Antoni Borrell

Abstract

Objective: To assess the impact of prenatal genetic counseling on the attitudes and preferences toward invasive testing in first-trimester pregnant women.

Methods: This is a randomized open-label study, of pregnant women undergoing first trimester combined screening for aneuploidies. Women were divided into the experimental or control groups in a 1:1 design. The intervention consisted of 15-min extra counseling about prenatal screening and diagnosis. The main outcome was the desire to choose an invasive testing as their first prenatal testing option which was measured as absolute risk.

Results: After excluding those with incomplete data, 75 women remained in the experimental group and 75 as controls. Women receiving counseling were 32% more likely to choose an invasive prenatal testing as their first-line option after extra 15-min extensive counseling, reducing the first-trimester combined screening by 20% and the cell-free DNA by 12%. If given the opportunity, 59% of the women would like to be able to choose the prenatal test that suits their needs.

Conclusion: Women given an extensive prenatal counseling are more likely to choose an invasive testing as their first-line test in spite of the concerning risks.

Clinical trial registration: www.ClinicalTrials.gov, identifier NCT04119349.

Keywords: cell free DNA testing; fetal aneuploidy detection; invasive testing; prenatal genetic counseling; randomized-controlled trial.

Copyright © 2020 Paz y Miño, Martinez-Portilla, Pauta and Borrell.

Figures

FIGURE 1
FIGURE 1
CONSORT flow diagram for transparent reporting of trials showing the number of women eligible, those allocated, followed up, analyzed and reasons for exclusion.
FIGURE 2
FIGURE 2
Forest plot on the calculate absolute risk for each answer in the questionnaire comparing those women allocated in the intervention and control group. Numbers on the right side of the graph represent the absolute risk favoring counseling, while those answers on the left side favor no counseling.
FIGURE 3
FIGURE 3
Forest plot showing the odds ratio for the association between the willing to have an invasive procedure as first-line prenatal testing to the demographic characteristics of the included population after adjusting to previous counseling and all variables between each other.

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