The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice.

autonomy clinical trial dual role issue gender equity induction of labor informed consent justice medicalization of birth natural childbirth nonmedically indicated induction research ethics

Journal

American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476

Informations de publication

Date de publication:
Mar 2024
Historique:
received: 18 04 2023
revised: 18 07 2023
accepted: 23 07 2023
medline: 12 3 2024
pubmed: 27 8 2023
entrez: 26 8 2023
Statut: ppublish

Résumé

The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation.

Identifiants

pubmed: 37633577
pii: S0002-9378(23)00509-4
doi: 10.1016/j.ajog.2023.07.037
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

S775-S782

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Auteurs

Elie Azria (E)

Maternity Unit, Hospital Paris Saint-Joseph, FHU PREMA, Paris, France; Obstetrical Perinatal and Pediatric Epidemiology Research Team, CRESS, EPOPé, INSERM, INRA, Université de Paris Cité, Paris, France.

Thibaud Haaser (T)

Health and Research Ethics Centre, University Hospital of Bordeaux, Bordeaux, France; Sciences, Philosophie, Humanités, Université de Bordeaux-Université Bordeaux-Montaigne, Domaine Universitaire, Pessac, France.

Thomas Schmitz (T)

Obstetrical Perinatal and Pediatric Epidemiology Research Team, CRESS, EPOPé, INSERM, INRA, Université de Paris Cité, Paris, France; Department of Obstetrics and Gynaecology, Robert Debré Hospital, AP-HP, Paris Diderot University, Paris, France.

Alizée Froeliger (A)

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.

Hanane Bouchghoul (H)

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.

Hugo Madar (H)

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.

Beth L Pineles (BL)

Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Loïc Sentilhes (L)

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France. Electronic address: loicsentilhes@hotmail.com.

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Classifications MeSH