ArticlePrenatal diagnosis2025
Clinical Trials of Fetal Therapy With Continuing Neonatal Interventions: Legal Requirements and Customary Procedures Regarding Parental Consent. The BOOSTB4 Trial as a Case Study.
Article in Prenatal diagnosis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
objectiveTo analyze the legal consent requirements and customary procedures in clinical trials of fetal therapy with continuing neonatal interventions across four European countries using the BOOSTB4 trial as a case study.
methodsThe study of country-specific legal consent requirements and the actual consent procedures in the BOOSTB4 trial, incorporating surveys with the trial's principal investigators.
resultsPrenatal consent was obtained solely from the pregnant women in all participating countries, in line with legal requirements. However, in all countries both prospective parents were engaged in prenatal counseling. In Sweden, the Netherlands and Germany obtaining consent from both parents for continuing neonatal interventions is mandatory. In the United Kingdom, officially only the consent of one parent is required. Nevertheless, researchers there are cautious of including pregnant women or neonates if parents disagree to trial participation, a concern echoed by Dutch, German and Swedish researchers.
conclusionWhile the pregnant woman's autonomy is paramount for prenatal trial participation, trials involving continuing neonatal interventions should adopt a two-step prenatal counseling approach. This approach allows a distinction between consent for fetal and neonatal procedures and allows researchers to comprehend parental perspectives without undermining the pregnant woman's individual rights.
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Registered trials
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