Women’s knowledge, counseling experience, and decision-making regarding non-invasive prenatal testing (NIPT) as a statutory health insurance benefit in Germany: a multicenter cross-sectional survey

Abstract Background Since July 2022, non-invasive prenatal testing (NIPT) for trisomies 21, 18, and 13 has been available as a statutory health insurance (GKV) benefit in Germany. It is not a routine examination offered to all pregnant women; according to the Maternity Directives of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA), it is reimbursed in justified individual situations after physician-led counselling. While uptake data have been reported from the healthcare provider perspective, patients’ knowledge, counselling experiences, motivations, and intended post-test decisions have not been systematically studied in a multicenter German cohort since NIPT became a GKV benefit. Methods A multicenter, exploratory, anonymous questionnaire-based survey was conducted at seven prenatal diagnostic centres across Germany between June and November 2024. Pregnant women who had already undergone GKV-NIPT were invited to participate. The questionnaire addressed four domains: (1) counselling and informed consent, (2) factual knowledge about GKV-NIPT, (3) motivation for testing, and (4) reactions and intended post-test decisions. A composite knowledge score was calculated from six factual items (Q4, Q5, Q7–Q10); the intended use of confirmatory amniocentesis (Q17) was analysed exclusively as an outcome variable. Descriptive statistics and Spearman rank correlations were applied. Ethics approval was obtained from the University of Heidelberg Ethics Committee (S-259/2024). Results A total of 1252 questionnaires were distributed across the seven centres, of which 645 were returned (overall response rate 51.5%; range 25.3–77.3% across centres). Seventy-three questionnaires were excluded (70 because NIPT had not been performed at the participating centre, 3 invalid), leaving 572 datasets for analysis. The mean age was 32.9 years (SD 4.69). Most women (78.3%) reported receiving the mandatory GKV information booklet, and 79.0% felt ‘informed’ to ‘very well informed’. Factual knowledge was incomplete: 81.6% did not know that a preceding ultrasound examination affects the predictive value of NIPT. While 86.2% cited trisomy detection as their primary motivation, 44.8% also sought fetal sex determination. Following testing, 74.1% felt reassured. The composite knowledge score correlated with post-test reassurance (rₛ = 0.145, p = 0.001), but showed no association with the intended use of confirmatory amniocentesis (rₛ = 0.053, p = 0.229). A single item was associated with that intention: women aware that a positive NIPT result may require confirmatory amniocentesis (Q10) were more willing to undergo it (58.8% vs 42.4%; OR 1.94, 95% CI 1.32–2.85; p < 0.001). Age was not correlated with knowledge (rₛ = 0.058, p = 0.183). Conclusion GKV-NIPT is broadly accepted and perceived reassuringly by pregnant women in Germany. Specific knowledge deficits—especially regarding test limitations and confirmatory procedures—remain prevalent and are not adequately addressed by current mandatory information materials. General factual knowledge did not predict the intended use of confirmatory amniocentesis; only the specific awareness that confirmation may be required did. Pre-test counselling should, therefore, convey defined, decision-relevant facts rather than information volume. The high prevalence of sex determination as a co-motivation warrants further ethical and policy discussion.