Evidence map›Paper›PMID 38069681›Full record

ArticlePrenatal diagnosis2024

Precarious hope: Ethical considerations for offering experimental fetal therapies outside of research after initial studies in humans.

Saskia Hendriks, Janyne Althaus, Meredith A Atkinson, Ahmet A Baschat, Benjamin E Berkman, Christine Grady, David Wasserman, David Wendler, Jena L Miller

Open access · greenAbstract read
In one paragraph

Article in Prenatal diagnosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
5.2field-weighted citation impact, top 5% of its field
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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Bilateral renal agenesis: fetal intervention and outcomes.Pediatric nephrology (Berlin, Germany) · 2025
    Review
  4. Review
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

9 authors at 5 institutions in 1 country.

Saskia HendriksDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
Janyne AlthausDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Maryland, Baltimore, Maryland, USA.
Meredith A AtkinsonDepartment of Pediatrics, Division of Nephrology, Johns Hopkins University, Baltimore, Maryland, USA.
Ahmet A BaschatDepartment of Gynecology and Obstetrics, Center for Fetal Therapy, Johns Hopkins University, Baltimore, Maryland, USA.
Benjamin E BerkmanDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
Christine GradyDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
David WassermanDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
David WendlerDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
Jena L MillerDepartment of Gynecology and Obstetrics, Center for Fetal Therapy, Johns Hopkins University, Baltimore, Maryland, USA.
National Institutes of Health Clinical Center · USJohns Hopkins University · USJohns Hopkins Center for Communication Programs · USNational Human Genome Research Institute · USUniversity of Maryland, Baltimore · US

Funding

Renal Anhydramnios Fetal Therapy (RAFT) TrialR01HD100540 · NICHD · JOHNS HOPKINS UNIVERSITY · PI ATKINSON, MEREDITH ANN, MILLER, JENA L · 2020 to 2024
$3.2M
Intramural NIH HHS Z99 CL999999NICHD NIH HHS R01 HD100540NIH HHS
6 · The paper itself

Abstract

objectiveRisks and benefits of experimental fetal therapies can remain uncertain after initial clinical studies, especially long-term effects. Nevertheless, pregnant individuals may request them, hoping to benefit their future child. Guidance about offering experimental fetal therapies outside research (as "innovative therapy") is limited, despite their ethical complexity. We propose points for clinicians and reviewers to consider when deciding whether and how to offer experimental fetal therapies as innovative therapies after initial clinical studies.

methodWe used conceptual analysis and a current case to develop points for consideration, grounded in broader debates on innovative therapy and the unique challenges associated with experimental fetal therapies.

resultsClinicians should evaluate whether offering experimental fetal therapies as innovative therapy is appropriate for a pregnant individual and their fetus. The anticipated risk-benefit ratio for the fetus should be favorable. For the pregnant individual, risks may outweigh benefits, within reasonable limits. Medical resources should be sufficient to ensure appropriate care. Clinicians should support pregnant individuals in making informed choices. Clinicians offering innovative therapies with more than minimal risk should collect and report data on outcomes. Independent review should take place.

conclusionConsidering these points may advance the interests of fetuses, future children, and their families.

Indexed as

Fetal TherapiesPrenatal CareChildFemaleFetusHumansPregnancyRisk AssessmentTherapies, Investigational

Identifiers

PMID38069681
PMCPMC10932810
OpenAlexW4389506457

What OpenQuestion holds

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Registered trials

None linked

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.