Evidence map›Paper›PMID 40240874›Full record

ArticlePediatric research2025

Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals' and parental perspectives.

Angret de Boer, André Krom, Rania Kalaai, Marieke de Vries, Marije Hogeveen, Sylvia A Obermann-Borst, Marijn Vermeulen, Juliette S van Haren, Peter Andriessen, Martine C de Vries and 2 more

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In one paragraph

Article in Pediatric research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Angret de BoerDepartment of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
André KromDepartment of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands.
Rania KalaaiDepartment of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands.
Marieke de VriesInstitute for Computing and Information Sciences (iCIS), Radboud University, Nijmegen, The Netherlands.
Marije HogeveenDepartment of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands.
Sylvia A Obermann-BorstCare4Neo, Neonatal patient and parent advocacy organization, Rotterdam, The Netherlands.
Marijn VermeulenCare4Neo, Neonatal patient and parent advocacy organization, Rotterdam, The Netherlands.
Juliette S van HarenDepartment of Industrial Design, Eindhoven University of Technology, Eindhoven, The Netherlands.
Peter AndriessenDepartment of Neonatology, Máxima Medical Center, Veldhoven, The Netherlands.
Martine C de VriesDepartment of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands.
E J T VerweijDepartment of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
Rosa GeurtzenDepartment of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands. rosa.geurtzen@radboudumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Artificial Amnion and Placenta Technology (AAPT) is developed to improve outcomes of extremely premature birth, with first in-human trials expected in the coming years. Empirical research with key stakeholders is essential for responsibly designing these trials. This study aims to discuss considerations for counselling and informed consent for the first in-human trials of the AAPT, discussing legal and ethical considerations.

methodsA qualitative study using both individual and focus group interviews with healthcare professionals (HCPs) and parents was performed. Interviews were thematically analysed.

resultsFifteen parents and 46 HCPs were interviewed. The results are represented into key themes reflecting participants' perspectives on: (I) the moral and legal status of the subject treated in AAPT trials, (II) the first participant: the pregnant person, and (III) the terminology used to describe the technology. Furthermore, considerations around the informed consent process and counselling, including parental hope, are described. The findings suggest these factors are interconnected, as the moral and legal context surrounding AAPT trials influences the approach to counselling and informed consent.

conclusionResolving key ethical and legal issues important for counselling and informed consent is essential for establishing parental right and the development of a responsible, ethically sound informed consent process. IMPACT: Addressing ethical and legal issues surrounding counseling and informed consent is essential to safeguard a responsible and ethically sound consent process for future human artificial amnion and placenta technology (AAPT)-trials. This is the first study exploring stakeholder perspectives on the AAPT, highlighting the complexities in counselling and informed consent, such as the moral status of participants and the rights of all parties, which must be carefully navigated before trial designs can progress. The article underscores the importance of establishing consensus and maintaining open dialogue among all stakeholders to create a robust, ethically grounded framework for informed consent in future trials.

Indexed as

AmnionCounselingHealth PersonnelInformed ConsentParentsPlacentaAdultAttitude of Health PersonnelFemaleFocus GroupsHumansMalePregnancyQualitative Research

Identifiers

PMID40240874

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.